[Federal Register: September 23, 1999 (Volume 64, Number 184)]
[Notices]               
[Page 51589-51654]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se99-128]                         


[[Page 51589]]

_______________________________________________________________________

Part II





Department of Health and Human Services





_______________________________________________________________________



Centers for Disease Control and Prevention



_______________________________________________________________________



Notice of Specific List for Categorization of Laboratory Test Systems, 
Assays, and Examinations by Complexity; Notice


[[Page 51590]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

 
Notice of Specific List for Categorization of Laboratory Test 
Systems, Assays, and Examinations by Complexity

AGENCY: Centers for Disease Control and Prevention (CDC),Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: Regulations at 42 CFR 493.15 and 493.17, implementing the 
Clinical Laboratory Improvement Amendments of 1988 (CLIA), Pub. L. 100-
578 (codified at 42 U.S.C. 263a), require that the Secretary provide 
for the categorization of specific laboratory test systems, assays, and 
examinations by level of complexity. The criteria for such 
categorizations also are set forth in those regulations.
    This Notice announces the addition of approximately 5,700 test 
systems, assays, and examinations that have been categorized with 
categorization notification to manufacturers between January 1, 1997 
and September 3, 1999. These categorizations were effective on the 
issue date of the notification letter sent to the manufacturer. CDC 
invites comments on the tests initially categorized in this Notice and 
reserves the right to reevaluate and recategorize tests based on the 
comments received in response to this Notice.
    CDC, The Food and Drug Administration (FDA) and the Health Care 
Financing Administration have agreed to the transfer of the test 
categorization responsibility to the FDA, and the transfer is in 
process. When the transfer is completed, manufacturers will be able to 
submit premarket applications for products and requests for complexity 
categorization of these products under CLIA to one agency. FDA is 
expected to assume test categorization responsibilities on or about 
January 31, 2000. Until FDA assumes responsibility for test 
categorization, CDC will continue to perform complexity determinations 
and categorization requests should be sent to the CDC.

DATES: Effective date: All categorizations in this Notice were 
effective on the date of the test categorization notification letter 
sent to the manufacturer. Written comments on the tests initially 
categorized in this Notice will be considered if they are received at 
the address indicated below, by no later than 5 p.m. on October 25, 
1999. CDC reserves the right to reevaluate and recategorize tests based 
on the comments received in response to this Notice.

ADDRESSES: Comments on the categorization of tests in this Notice 
should be addressed to CLIA Federal Register Notice, Centers for 
Disease Control and Prevention, Public Health Practice Program Office, 
Mail Stop F-11, 4770 Buford Highway, NE, Atlanta, Georgia 30341-3724.
    Requests for test complexity categorization should be submitted to: 
Attention: Test Categorization/CLIA, Centers for Disease Control and 
Prevention, Public Health Practice Program Office, Mail Stop F-11, 4770 
Buford Highway, NE, Atlanta, Georgia 30341-3724.
    Requests for waiver status should be submitted to: Attention: 
Request for Waiver Status/CLIA, Centers for Disease Control and 
Prevention, Public Health Practice Program Office, Mail Stop F-11, 4770 
Buford Highway, NE, Atlanta, GA 30341-3724.
    Due to staffing and resource limitations, we cannot accept 
facsimile (FAX) copies of comments. Nor can we accept comments by 
telephone.

FOR FURTHER INFORMATION CONTACT: Sharon Granade, (770) 488-8155.

SUPPLEMENTARY INFORMATION: All requests for test categorization should 
be submitted to CDC. Manufacturers are requested to submit the package 
insert and/or an Operator's Manual along with the 510(k) or Pre-Market 
Approval (PMA) number for the product, if applicable, to CDC when 
requesting categorization. Although some products may now be exempt 
from FDA's 510(k) review process, they continue to need evaluation for 
complexity categorization under CLIA. For products undergoing the 
510(k) or PMA review process, CDC will not be able to issue the test 
categorization until the FDA has completed its review process and has 
notified CDC of the clearance date. Test categorizations are effective 
as of the date of notification by CDC to the applicant. Updates and 
revisions to the CLIA test categorization list are periodically 
published in the Federal Register with an opportunity for public 
comment. CDC also maintains an electronic list of categorized tests 
which is available via the Internet (http://www.phppo.cdc.gov/DLS/clia/
testcat.asp).

Effect of Waiver on Tests Already in Use

    For test systems in use prior to waiver approval, any modifications 
to the device or instructions that were required for waiver approval 
must be incorporated into those existing test systems for use of such 
test systems to be considered waived. (Pending such modifications, the 
particular test system already in use by a laboratory will retain its 
prior test categorization.)

Waived Tests Marketed Under Alternate Product Names

    Frequently, products which have been granted waived status are 
later repackaged and marketed under alternate product names. In these 
cases, it is the responsibility of the manufacturer to notify CDC and 
to send the package insert demonstrating the new labeling along with 
all sets of instructions that apply (e.g., if separate instructions for 
home use and for professional use exist, send a copy of both sets of 
instructions). Even though a test may be waived under one product name, 
it is not considered waived under an alternate name until it is 
reviewed by CDC and the manufacturer is notified of the waived status.

Comments and Responses

    On April 11, 1997, a test list of approximately 1,300 additional 
test systems, assays, and examinations categorized by level of 
complexity was published in the Federal Register (62 FR 17832) with a 
30 day comment period. CDC received no comment letters in regard to 
this Notice.

Analyte Clarification

    A new analyte name, ``D-Dimer'' (Analyte code 1320), was created 
for the measurement of this specific fibrin degradation product. Test 
systems measuring D-Dimer, but previously categorized under the broader 
analyte name (1904) Fibrin(ogen) Split/Degradation Products (FSP/FDP), 
are now listed under the new analyte name. The analyte name 
Fibrin(ogen) Split/Degradation Products (FSP/FDP) will continue to be 
used for measurements not specific to a particular degradation product.
    The analyte (5828) Streptococcus, group A (from throat only) was 
deleted and the test systems categorized for this analyte are now 
listed under the analyte (5810) Streptococcus, group A. The test system 
qualifier ``Direct Antigen/Visual'', associated with this analyte, was 
replaced with ``Direct from throat swab.''
    For consistency with the listing of other autoantibodies, the 
analyte (6135) Thyroid Peroxidase Autoantibodies (TPO) was replaced 
with (0527) Anti-Thyroid Peroxidase (TPO) Antibodies.
    The analyte (0708) ``Blood gases with pH'' was modified to 
accommodate the

[[Page 51591]]

technological advances that allow direct measurement of analytes that 
previously were calculated. The analyte code (0708) now refers to the 
analyte name ``Blood gases'' and the analytes for pH, pCO2, and pO2 
were assigned individual analyte codes: (4982) pH, (4983) pCO2, (4984) 
pO2. To avoid confusion, the analyte (0731) All Body Fluids (other than 
blood) pH was deleted, and the test system (04542) All Qualitative 
Dipstick Color Comparison pH Testing, categorized under the deleted 
analyte, was reassigned to the new analyte (4982) pH.
    For clarity and consistency and to reflect current nomenclature, 
the following analyte names and codes were changed:

From (0735) B1 positive Lymphocytes to (3758) Lymphocytes, CD20;
From (0736) B4 positive Lymphocytes to (3759) Lymphocytes, CD19;
From (1111) CD3(IgG1)positive Lymphocytes, (1110) CD3 positive 
Lymphocytes, and (6149) T3 positive Lymphocytes to (3760) Lymphocytes, 
CD3;
From (1116) CD4 positive Lymphocytes and (6150) T4 positive Lymphocytes 
to (3761) Lymphocytes, CD4;
From (4033) MY4 positive Lymphocytes to (4040) Monocytes, CD14(MY4);
From (4034) Mo2 positive Lymphocytes to (4041) Monocytes, CD14(Mo2);
From (6145 and 6157) T1 positive Lymphocytes (duplication of codes) to 
(3762) Lymphocytes, CD5;
From (6146) T11 positive Lymphocytes to (3763) Lymphocytes, CD2;
From (6152) T8 positive Lymphocytes and (1118) CD8 positive Lymphocytes 
to (3764) Lymphocytes, CD8;
From (1112) CD3(IgG1)/B4 positive Lymphocytes to (3765) Lymphocytes, 
CD3/CD19;
From (1113) CD3(IgG1)/T4 positive Lymphocytes and (1117) CD4/CD3 
positive Lymphocytes to (3766) Lymphocytes, CD3/CD4;
From (1114) CD3(IgG1)/T8 positive Lymphocytes and (1119) CD8/CD3 
positive Lymphocytes to (3767) Lymphocytes, CD3/CD8;
From (1120) CD3/CD19/CD45 positive Lymphocytes to (3768) Lymphocytes, 
CD3/CD19/CD45;
From (1121) CD3/CD4/CD45 positive Lymphocytes to (3769) Lymphocytes, 
CD3/CD4/CD45;
From (1115) CD3/HLA-DR positive Lymphocytes to (3770) Lymphocytes, CD3/
HLA-DR;
From (1122) CD3/T4/T8 positive Lymphocytes to (3771) Lymphocytes, CD3/
CD4/CD8;
From (6147) T11/B1 positive Lymphocytes to (3772) Lymphocytes, CD2/
CD20;
From (6148) T11/B4 positive Lymphocytes to (3773) Lymphocytes, CD2/
CD19;
From (6151) T4/T8 positive Lymphocytes to (3774) Lymphocytes, CD4/CD8.

Manufacturer Listing

    For data entry reasons, the manufacturer Reference Diagnostics, 
Inc. is now denoted in the Test Categorization list as RDI and the 
manufacturer International Technidyne Corp. is denoted as ITC.

Correction

    Due to a data entry error, an incorrect categorization for the 
analyte (6404) Uric Acid on the test system (04036) Abbott Bichromatic 
ABA 200 was published as moderate complexity in the April 11, 1997 
Federal Register (62 FR 17832). The correct categorization for Uric 
Acid on this instrument is high complexity.

    Dated: September 16, 1999.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention.

List of Previously Unpublished Categorizations

    The test categorization scoring scheme was based on an assessment 
of the complexity of the operation of the test procedure and not on an 
evaluation of data documenting the procedure's performance over time. 
Therefore, the categorization of a test system, assay, or examination 
as moderate or high complexity should not be interpreted as an 
indication of the acceptability or unacceptability of the accuracy, 
precision, or overall performance of the procedure.

COMPLEXITY: MODERATE

SPECIALTY/SUBSPECIALTY: BACTERIOLOGY

ANALYTE: Aerobic &/or Anaerobic Organisms-unlimited sources (0412)

Test System, Assay, Examination:
    Organon Teknika BacT/ALERT 3D (46292)

ANALYTE: Aerobic Organisms from urine specimens only (0468)

Test System, Assay, Examination:
    Sanofi Pasteur UriSelect 3 (colony count only) (58540)
    Wyeth-Ayerst Laboratories Testuria Screen (colony count only) 
(70207)
    bioMerieux Vitek CPS ID 2 (colony count only) (07930)

ANALYTE: Aerobic organisms from salivary specimens only (0543)

Test System, Assay, Examination:
    Orion Diagnostica Dentocult LB Culture Paddles (46299)

ANALYTE: Clostridium difficile (1022)

Test System, Assay, Examination:
    Becton Dickinson ColorPAC Toxin A Test (direct Ag/visual) (08170)
    Biosite Triage Clostridium difficile Panel (08111)

ANALYTE: Escherichia coli (1604)

Test System, Assay, Examination:
    Universal HealthWatch Quix Rapid E. coli 0157 Strip Test (64043)

ANALYTE: Gardnerella vaginalis (2212)

Test System, Assay, Examination:
    Becton Dickinson Affirm VPIII Microbial Identification Test (07852)
    Litmus Concepts Indicard Test (from vaginal swab) (37110)

ANALYTE: Helicobacter pylori (2512)

Test System, Assay, Examination:
    Medical Instruments Pronto Dry (40331)
    Remel Selective Rapid Urea (55238)

ANALYTE: Salmonella (5802)

Test System, Assay, Examination:
    The Binding Site Salmonella typhi Vi Suspension (61434)

ANALYTE: Streptococcus, group A (5810)

Test System, Assay, Examination:
    Abbott TestPack Plus Strep A with OBC II (direct from throat swab) 
(04810)
    BioStar Strep A OIA MAX (direct from throat swab) (07826)
    Excel Scientific Strep A-OneStep Group A Antigen Module Test 
(direct from throat swab) (16135)
    LifeSign UniStep Strep A (direct from throat swab) (37123)
    Princeton BioMeditech BioSign Strep A (direct from throat swab) 
(49120)
    Trinity Biotech Uni-Gold Strep A (direct from throat swab) (61393)

ANALYTE: Vibrio cholerae (6716)

Test System, Assay, Examination:
    Universal HealthWatch Quix Rapid Cholera Strip Test (64044)

SPECIALTY/SUBSPECIALTY: ENDOCRINOLOGY

ANALYTE: Adrenocorticotropic Hormone (ACTH) (0458)

Test System, Assay, Examination:
    Cirrus Diagnostics Immulite 2000 (10418)
    Nichols Institute Advantage Chemiluminescence System (43122)

ANALYTE: Calcitonin (1041)

Test System, Assay, Examination:

[[Page 51592]]

    Nichols Institute Advantage Chemiluminescence System (43122)

ANALYTE: Collagen Type I Crosslink, Deoxypyridinoline (Dpd) (1127)

Test System, Assay, Examination:
    Bayer Immuno 1 System (08123)
    Cirrus Diagnostics Immulite (10159)
    Cirrus Diagnostics Immulite 2000 (10418)

ANALYTE: Collagen Type I Crosslink, N-telopeptides (NTx) (1125)

Test System, Assay, Examination:
    Ortho-Clinical Diagnostics Vitros ECi (46279)

ANALYTE: Cortisol (1032)

Test System, Assay, Examination:
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Chiron Diagnostics ACS: Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Nichols Institute Advantage Chemiluminescence System (43122)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 914 (55549)
    TOSOH AIA NexIA (61295)

ANALYTE: Cortisol, Urine (direct procedure) (1033)

Test System, Assay, Examination:
    Beckman ACCESS Immunoassay System (07914)
    Chiron Diagnostics ACS: Centaur (10440)

ANALYTE: Dehydroepiandrosterone Sulfate (DHEA-SO<INF>4</INF>) (1310)

Test System, Assay, Examination:
    Cirrus Diagnostics Immulite 2000 (10418)
    Nichols Institute Advantage Chemiluminescence System (43122)

ANALYTE: Estradiol (1605)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS: Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Johnson & Johnson Vitros ECi (31076)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    Sanofi Pasteur Access Immunoassay System (58257)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: Estriol, unconjugated (1607)

Test System, Assay, Examination:
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)

ANALYTE: Follicle Stimulating Hormone (FSH) (1908)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS: Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Behring aca IV (with aca plus Immunoassay System) (13527)
    Dade Behring aca Star (with aca plus Immunoassay System) (13523)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Johnson & Johnson Vitros ECi (31076)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: HCG Beta Serum, Quantitative--Extended Range (ER) (2566)

Test System, Assay, Examination:
    Bayer Immuno 1 System (08123)

ANALYTE: HCG, Beta, Serum, Quantitative (2502)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Chiron Diagnostics ACS:Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Behring aca IV (with aca plus Immunoassay System) (13527)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Johnson & Johnson Vitros ECi (31076)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: HCG, Intact, Serum, Quantitative (2567)

Test System, Assay, Examination:
    Dade Behring Dimension RxL (13519)
    Dade Behring aca Star (with aca plus Immunoassay System) (13523)
    Dade Dimension RxL (13436)
    TOSOH A1A-1200 (61040)
    TOSOH A1A-1200DX (61154)
    TOSOH A1A-600 (61039)
    TOSOH AIA NexIA (61295)

ANALYTE: HCG, Serum, Qualitative (2501)

Test System, Assay, Examination:
    ACON hCG Urine/Serum One Step Pregnancy Test Strip (04791)
    Abbott TestPack +Plus hCG COMBO with OBC (04724)
    Alfa Scientific Designs Instant-View Pregnancy Combo Test 
(Cassette) (04846)
    Alfa Scientific Designs Instant-View Pregnancy Combo Test (Dip-
Strip) (04847)
    AmeriTek One Step dBest Pregnancy Test Disk (04788)
    AmeriTek One Step dBest Pregnancy Test Strip (04787)
    Applied Biotech SureStep hCG Combo (II) Pregnancy Test (04869)
    Arlington Scientific ProPhase Combo S/U OneStep hCG (04697)
    Bionike A/Q Pregnancy Test (07779)
    Germaine Laboratories AimStep Combo Pregnancy (22246)
    Germaine Laboratories AimStick PBD

[[Page 51593]]

Combo Pregnancy (22248)
    Global Medika PregnaStrip S/U HCG (22227)
    Global Medika PregnaTest S/U hCG Cassette Pregnancy Test (22237)
    Jant Pharmacal accutest RAPID URINE/SERUM Pregnancy Test (31084)
    LifeSign UniStep hCG (37124)
    Medika Bio-Tech PregnaTest S/U (cassette) (40322)
    Meridian Diagnostics ImmunoCard STAT hCG Combo (40328)
    Orion Diagnostica UniStep hCG II (46224)
    Quidel CARDS Q.S. hCG Serum/Urine (52062)
    Quidel Concise Performance Plus hCG-Combo (52063)
    Quidel QuickVue One-Step hCG-Combo (52061)
    Quidel QuickVue Semi-Q hCG -Combo (52068)
    Roche Diagnostics AccuStat hCG/Diluent Reagent (55328)
    Simex Medical DiagnoStrip hCG-Combo (58511)
    Simex Medical DiagnoStrip hCG-Serum (58433)
    SmithKline ICON Fx hCG Urine/Serum Test (58514)
    TECO Diagnostics One-Step Combo Pregnancy Card Test (61281)
    TECO Diagnostics One-Step Combo Pregnancy Dipstick Test (61282)
    TECO Diagnostics Visual HCG Pregnancy Test (61430)

ANALYTE: HCG, Total, Serum, Quantitative (2555)

Test System, Assay, Examination:
    AlfaBioTech AuraFlex (04772)
    Chiron Diagnostics ACS:Centaur (10440)
    Serono Baker SR1/ BioChem SR1 hCG (58471)

ANALYTE: HCG, Urine (2503)

Test System, Assay, Examination:
    AlfaBioTech AuraFlex (04772)
    Arlington Scientific Pregnancy Latex Slide Test (04702)
    Bayer CLINITEK 100 Urine Chemistry Analyzer (07918)
    Immunostics PREGNACOL (28512)
    TECO Diagnostics Direct Pregnancy Test (61431)

ANALYTE: Human Growth Hormone (GH) (2547)

Test System, Assay, Examination:
    Cirrus Diagnostics Immulite 2000 (10418)
    Nichols Institute Advantage Chemiluminescence System (43122)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: Human Placental Lactogen (hPL) (2533)

Test System, Assay, Examination:
    Cirrus Diagnostics Immulite 2000 (10418)

ANALYTE: Insulin (2812)

Test System, Assay, Examination:
    Beckman ACCESS Immunoassay System (07914)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: Insulin-like Growth Factor-1 (IGF-1) (2818)

Test System, Assay, Examination:
    Nichols Institute Advantage Chemiluminescence System (43122)

ANALYTE: Luteinizing Hormone (LH) (3713)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS:Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Behring aca IV (with aca plus Immunoassay System) (13527)
    Dade Behring aca Star (13521)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Johnson & Johnson Vitros ECi (31076)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: Parathyroid Hormone--Intact (4924)

Test System, Assay, Examination:
    Cirrus Diagnostics Immulite 2000 (10418)
    Nichols Institute Advantage Chemiluminescence System (43122)

ANALYTE: Progesterone (4914)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Behring OPUS (07793)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS:Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Johnson & Johnson Vitros ECi (31076)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)
    bioMerieux Vitek VIDAS (07806)

ANALYTE: Prolactin (4915)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS:Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Behring aca IV (with aca plus Immunoassay System) (13527)
    Dade Behring aca Star (with aca plus Immunoassay System) (13523)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Johnson & Johnson Vitros ECi (31076)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: Sex Hormone Binding Globulin (5819)

Test System, Assay, Examination:
    Cirrus Diagnostics Immulite 2000 (10418)

ANALYTE: T Uptake (TU) (6156)

Test System, Assay, Examination:
    AlfaBioTech AuraFlex (04772)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)

[[Page 51594]]

    Chiron Diagnostics ACS: Centaur (10440)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca Star (13521)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: Testosterone (6102)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS: Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Organon Teknika AuraFlex (46152)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)

ANALYTE: Thyroid Stimulating Hormone (TSH) (6106)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    AlfaBioTech AuraFlex (04772)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Chiron Diagnostics ACS: Centaur (10440)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (with aca plus Immunoassay System) (13527)
    Dade Behring aca Star (with aca plus Immunoassay System) (13523)
    Dade Dimension RxL (13436)
    Dade Stratus (13485)
    Johnson & Johnson Vitros ECi (31076)
    Little Nell Labs ThyroChek (37147)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: Thyroid Stimulating Hormone (TSH) (Neonatal) (6107)

Test System, Assay, Examination:
    Wallac Oy AutoDELFIA (70167)

ANALYTE: Thyroid Stimulating Hormone (TSH) Third Generation (6155)

Test System, Assay, Examination:
    Abbott AxSYM (04532)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Cirrus Diagnostics Immulite 2000 (10418)
    Nichols Institute Advantage Chemiluminescence System (43122)
    TOSOH AIA NexIA (61295)

ANALYTE: Thyroid Stimulating Hormone--high sens. (TSH-HS) (6108)

Test System, Assay, Examination:
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)

ANALYTE: Thyroxine (T4) (6109)

    Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Chiron Diagnostics ACS:Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Johnson & Johnson Vitros ECi (31076)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: Thyroxine Binding Globulin (TBG) (6110)

Test System, Assay, Examination:
    Bayer Immuno 1 System (08123)
    Cirrus Diagnostics Immulite 2000 (10418)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)

ANALYTE: Thyroxine, Free (FT4) (6111)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Biocircuits IOS (07745)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Chiron Diagnostics ACS:Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (with aca plus Immunoassay System) (13527)
    Dade Dimension RxL (13436)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Johnson & Johnson Vitros ECi (31076)
    Nichols Institute Advantage Chemiluminescence System (43122)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)

[[Page 51595]]

    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: Triiodothyronine (T3) (6119)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Chiron Diagnostics ACS:Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Johnson & Johnson Vitros ECi (31076)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    TOSOH AIA NexIA (61295)

ANALYTE: Triiodothyronine Uptake (T-Uptake) (TU) (6120)

Test System, Assay, Examination:
    Roche Diagnostics Hitachi 902 (55598)

ANALYTE: Triiodothyronine Uptake (T3U) (TU) (6120)

Test System, Assay, Examination:
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Behring Dimension AR (13517)
    Dade Behring aca IV (13525)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Johnson & Johnson Vitros ECi (31076)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 914 (55549)

ANALYTE: Triiodothyronine, Free (FT3) (6121)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    Abbott AxSYM (04532)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Boehringer Mannheim ES 300 (07160)
    Boehringer Mannheim ES 300 AL (07524)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS:Centaur (10440)
    Cirrus Diagnostics Immulite (10159)
    Johnson & Johnson Vitros ECi (31076)
    Nichols Institute Advantage Chemiluminescence System (43122)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    TOSOH AIA NexIA (61295)

SPECIALTY/SUBSPECIALTY: GENERAL CHEMISTRY

ANALYTE: 5'Nucleotidase (0105)

Test System, Assay, Examination:
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)

ANALYTE: Acid Phosphatase (0407)

Test System, Assay, Examination:
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)

ANALYTE: Alanine Aminotransferase (ALT) (SGPT) (0404)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    HCL Laboratory Systems 200 Biochemistry Analyzer (25266)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550

[[Page 51596]]

(46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Roche Diagnostics Reflotron (55580)
    Roche Diagnostics Reflotron Plus (55582)
    Synermed IR 200 (58460)

ANALYTE: Albumin (0414)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman IMMAGE Immunochemistry System (07816)
    Beckman QM 300 Protein System (07915)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    CARESIDE CareSide Analyzer (10445)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    HCL Laboratory Systems 200 Biochemistry Analyzer (25266)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Synermed IR 200 (58460)

ANALYTE: Albumin, Urinary (0516)

Test System, Assay, Examination:
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)

ANALYTE: Albumin/Globulin (A/G) Ratio (0539)

Test System, Assay, Examination:
    CARESIDE CareSide Analyzer (10445)

ANALYTE: Aldolase (0415)

Test System, Assay, Examination:
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 914 (55549)

ANALYTE: Alkaline Phosphatase (ALP) (0416)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    CARESIDE CareSide Analyzer (10445)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Synermed IR 200 (58460)

ANALYTE: Alkaline Phosphatase Bone Specific (BAP) (0518)

Test System, Assay, Examination:
    Behring OPUS (07793)
    Behring OPUS Magnum (07794)

[[Page 51597]]

    Behring OPUS Plus (07795)

ANALYTE: Alpha-Hydroxybutyrate Dehydrogenase (HBDH) (0419)

Test System, Assay, Examination:
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)

ANALYTE: Ammonia, Plasma/Serum (0427)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DT60 Chemistry System (31074)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DT60 (46277)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)

ANALYTE: Amylase (0429)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    CARESIDE CareSide Analyzer (10445)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    HCL Laboratory Systems 200 Biochemistry Analyzer (25266)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DT60 Chemistry System (31074)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DT60 (46277)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Roche Diagnostics Reflotron (55580)
    Roche Diagnostics Reflotron Plus (55582)
    Synermed IR 200 (58460)

ANALYTE: Amylase, pancreatic isoenzymes (p-Amylase) (0500)

Test System, Assay, Examination:
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)

ANALYTE: Angiotensin Converting Enzyme (ACE) (0481)

Test System, Assay, Examination:
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)

ANALYTE: Apolipoprotein A1 (0462)

Test System, Assay, Examination:
    Beckman IMMAGE Immunochemistry System (07816)
    Beckman QM 300 Protein System (07915)
    Beckman Synchron LX System

[[Page 51598]]

(08076)
    Boehringer Mannheim Hitachi 704 {Crestat N-Assay TIA APO A1} 
(08027)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 704 {Crestat N-Assay TIA APO A1} (55377)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)

ANALYTE: Apolipoprotein B (0457)

Test System, Assay, Examination:
    Beckman IMMAGE Immunochemistry System (07816)
    Beckman QM 300 Protein System (07915)
    Beckman Synchron LX System (08076)
    Boehringer Mannheim Hitachi 717 {Crestat N-Assay TIA APO B} (08044)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 717 {Crestat N-Assay TIA APO B} (55412)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)

ANALYTE: Aspartate Aminotransferase (AST) (SGOT) (0405)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    CARESIDE CareSide Analyzer (10445)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    HCL Laboratory Systems 200 Biochemistry Analyzer (25266)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Roche Diagnostics Reflotron (55580)
    Roche Diagnostics Reflotron Plus (55582)
    Synermed IR 200 (58460)

ANALYTE: Beta-Hydroxybutyrate (0722)

Test System, Assay, Examination:
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 747 (55480)

ANALYTE: Bile Acids (0747)

Test System, Assay, Examination:
    BioAutoMed ASCA {TECO Bile Acids} (07917)
    Roche Cobas Mira Plus {TECO Bile Acids} (55237)
    Roche Diagnostics Hitachi 911 {Marukin Shoyu UBAS Assay} (55597)

ANALYTE: Bilirubin, Direct (0704)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)

[[Page 51599]]

    Synermed IR 200 (58460)

ANALYTE: Bilirubin, Neonatal (0705)

Test System, Assay, Examination:
    Abbott Aeroset (04798)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Instrumentation Laboratory IL Synthesis (28466)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros DT60 Chemistry System (31074)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros DT60 (46277)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi Modular Analytics (55619)

ANALYTE: Bilirubin, Total (0706)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    CARESIDE CareSide Analyzer (10445)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    HCL Laboratory Systems 200 Biochemistry Analyzer (25266)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DT60 Chemistry System (31074)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DT60 (46277)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Roche Diagnostics Reflotron (55580)
    Roche Diagnostics Reflotron Plus (55582)
    Synermed IR 200 (58460)

ANALYTE: Bilirubin, Urine (0738)

Test System, Assay, Examination:
    Roche Diagnostics Hitachi 717 {Chimera UA PERFECT} (55410)

ANALYTE: Blood Gases (0708)

Test System, Assay, Examination:
    AVL OPTI Critical Care Analyzer (04778)
    Diametrics Medical IRMA SL Series 2000 {Diametrics Medical Multi-
use Cartridge} (13493)
    Medica EasyBloodGas Analyzer (40291)
    Nova Stat Profile Ultra L (43124)
    Nova Stat Profile Ultra M (43125)
    Nova Stat Profile pHOx (43123)
    Radiometer ABL 555 (55277)
    Radiometer ABL 700 Series (55298)
    Radiometer ABL System 600 (55231)
    Radiometer ABL System 610 (55230)
    Radiometer ABL System 620 (55229)

ANALYTE: C-Peptide (1040)

Test System, Assay, Examination:
    Cirrus Diagnostics Immulite 2000 (10418)
    TOSOH AIA NexIA (61295)

ANALYTE: Calcium, Ionized (1004)

Test System, Assay, Examination:
    AVL 9181 (04739)
    AVL OPTI Critical Care Analyzer (04778)
    Diametrics Medical IRMA SL Series 2000 {Diametrics Medical Chem 6 
Cartridge} (13492)
    Diametrics Medical IRMA SL Series 2000 {Diametrics Medical Multi-
use Cartridge} (13493)
    Medica EasyLyte Ca/Cl (40260)
    Nova Stat Profile Ultra L (43124)
    Nova Stat Profile Ultra M (43125)
    Radiometer ABL 555 (55277)
    Radiometer ABL 700 Series (55298)
    Radiometer ABL System 600 (55231)
    Radiometer ABL System 610 (55230)
    Radiometer ABL System 620 (55229)

ANALYTE: Calcium, Total (1005)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    CARESIDE CareSide Analyzer (10445)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC

[[Page 51600]]

Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Synermed IR 200 (58460)

ANALYTE: Cancer Antigen 125 (CA 125) (1049)

Test System, Assay, Examination:
    Abbott AxSYM (04532)
    Abbott IMX (04056)
    Bayer Immuno 1 System (08123)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics Hitachi 717 (55401)
    TOSOH A1A-1200 (61040)
    TOSOH A1A-1200DX (61154)
    TOSOH A1A-600 (61039)
    TOSOH AIA NexIA (61295)

ANALYTE: Cancer Antigen 15-3 (CA 15-3) (1068)

Test System, Assay, Examination:
    Abbott AxSYM (04532)
    Abbott IMX (04056)
    Bayer Immuno 1 System (08123)
    Ortho-Clinical Diagnostics Vitros ECi (46279)

ANALYTE: Cancer Antigen 27.29 (CA 27.29) (1132)

Test System, Assay, Examination:
    Chiron Diagnostics ACS 180 {Chiron ACS:180 BR} (10434)
    Chiron Diagnostics ACS 180 Plus {Chiron ACS:180 BR} (10435)
    Chiron Diagnostics ACS:Centaur {Chiron ACS:180 BR} (10440)

ANALYTE: Carbon Dioxide, Total (CO2) (1003)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Synermed IR 200 (58460)

ANALYTE: Carcinoembryonic Antigen (CEA) (1013)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Chiron Diagnostics ACS 180 (10375)
    Chiron Diagnostics ACS 180 Plus (10376)
    Chiron Diagnostics ACS: Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    TOSOH A1A-1200 (61040)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)
    Technicon Immuno 1 System (61042)

ANALYTE: Cerebrospinal Fluid (CSF) Protein (1014)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950

[[Page 51601]]

IRC (46276)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)

ANALYTE: Ceruloplasmin (1015)

Test System, Assay, Examination:
    Beckman IMMAGE Immunochemistry System (07816)
    Beckman QM 300 Protein System (07915)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi Modular Analytics (55619)

ANALYTE: Chloride (1018)

Test System, Assay, Examination:
    AVL 9181 (04739)
    AVL OPTI Critical Care Analyzer (04778)
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    CARESIDE CareSide Analyzer (10445)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Diametrics Medical IRMA SL Series 2000 {Diametrics Medical Chem 6 
Cartridge} (13492)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Medica EasyLyte Ca/Cl (40260)
    Medica EasyLyte Na/K/Cl/Li (40259)
    Nova Stat Profile Ultra L (43124)
    Nova Stat Profile Ultra M (43125)

    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Radiometer ABL 555 (55277)
    Radiometer ABL 700 Series (55298)
    Radiometer ABL System 600 (55231)
    Radiometer ABL System 610 (55230)
    Radiometer ABL System 620 (55229)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    SenDx 100 pH, Blood Gas and Electrolyte Analysis System (58390)

ANALYTE: Cholesterol (1020)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    CARESIDE CareSide Analyzer (10445)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DT60 Chemistry System (31074)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DT60 (46277)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Polymer Technology Systems MTM BioScanner 1000 (49196)
    Roche Diagnostics Accutrend GC Cholesterol Test (55330)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Roche Diagnostics ProAct System (55578)
    Roche Diagnostics Reflotron (55580)
    Roche Diagnostics Reflotron Plus (55582)
    Synermed IR 200 (58460)

ANALYTE: Cholinesterase (1021)

Test System, Assay, Examination:
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500

[[Page 51602]]

Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (plasma/serum/CSF) (55599)
    Roche Diagnostics Hitachi 902 (whole blood) (55600)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (plasma/serum/CSF) (55626)
    Roche Diagnostics Hitachi 912 (whole blood) (55625)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (plasma/serum/CSF) 
(55620)
    Roche Diagnostics Hitachi Modular Analytics (whole blood) (55621)

ANALYTE: Cholyglycine (1053)

Test System, Assay, Examination:
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)

ANALYTE: Creatine Kinase (CK) (1034)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    CARESIDE CareSide Analyzer (10445)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    First Medical Alpha Dx System (19034)
    HCL Laboratory Systems 200 Biochemistry Analyzer (25266)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Roche Diagnostics Reflotron (55580)
    Roche Diagnostics Reflotron Plus (55582)
    Synermed IR 200 (58460)

ANALYTE: Creatine Kinase MB Fraction (CKMB) (1002)

Test System, Assay, Examination:
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Biosite Triage Meter {Biosite Triage Cardiac Panel} (08057)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    CARESIDE CareSide Analyzer (10445)
    Chiron Diagnostics ACS:Centaur (10440)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring Stratus CS STAT (13498)
    Dade Behring aca IV (13525)
    Dade Behring aca IV (with aca plus Immunoassay System) (13527)
    Dade Behring aca Star (13521)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    First Medical Alpha Dx System (19034)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Johnson & Johnson Vitros ECi (31076)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Princeton BioMeditech Cardiac STATus CK-MB/Myoglobin/

[[Page 51603]]

Troponin I Rapid Test (49214)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Spectral Cardiac STATus CK-MB/Myoglobin (58581)
    Spectral Cardiac STATus CK-MB/Myoglobin/Troponin I (58580)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: Creatinine (1035)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Bayer CLINITEK 100 Urine Chemistry Analyzer (07918)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    CARESIDE CareSide Analyzer (10445)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    HCL Laboratory Systems 200 Biochemistry Analyzer (25266)
    I-STAT i-STAT 200 System (28344)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DT60 Chemistry System (31074)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DT60 (46277)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Roche Diagnostics Reflotron (55580)
    Roche Diagnostics Reflotron Plus (55582)
    Synermed IR 200 (58460)

ANALYTE: Cystine (1106)

Test System, Assay, Examination:
    Mission Pharmacal Urocystine (40263)

ANALYTE: Deoxyhemoglobin (Reduced Hemoglobin) (1318)

Test System, Assay, Examination:
    Radiometer ABL 700 Series (55298)
    Radiometer ABL System 620 (55229)

ANALYTE: Ferritin (1902)

Test System, Assay, Examination:
    Abbott ARCHITECT i System (04831)
    AlfaBioTech AuraFlex (04772)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Beckman IMMAGE Immunochemistry System (07816)
    Boehringer Mannheim Elecsys 1010 Analyzer (07916)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)
    Boehringer Mannheim Hitachi 704 {BM TinaQuant Ferritin} (08045)
    Boehringer Mannheim Hitachi 717 {BM TinaQuant Ferritin} (08046)
    Boehringer Mannheim Hitachi 911 {BM TinaQuant Ferritin} (08047)
    Boehringer Mannheim Hitachi 912 {BM TinaQuant Ferritin} (08048)
    Boehringer Mannheim Hitachi 914 {BM TinaQuant Ferritin} (08049)
    Boehringer Mannheim Hitachi 917 {BM TinaQuant Ferritin} (08050)
    Chiron Diagnostics ACS:Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Behring aca IV (with aca plus Immunoassay System) (13527)
    Dade Behring aca Star (with aca plus Immunoassay System) (13523)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Johnson & Johnson Vitros ECi (31076)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Olympus AU 800 (46110)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics ES 300 (55358)
    Roche Diagnostics ES 300 AL (55359)
    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    Roche Diagnostics Hitachi 704 {TinaQuant Ferritin} (55372)
    Roche Diagnostics Hitachi 717 {TinaQuant Ferritin} (55406)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 {TinaQuant Ferritin} (55518)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 912 {TinaQuant Ferritin} (55547)
    Roche Diagnostics Hitachi 914 {TinaQuant Ferritin} (55553)
    Roche Diagnostics Hitachi 917 {TinaQuant Ferritin} (55564)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    TOSOH A1A-1200DX (61154)
    TOSOH AIA NexIA (61295)

ANALYTE: Fetal Fibronectin (1934)

Test System, Assay, Examination:
    Adeza Biomedical TLi System {Rapid fFN Cassette} (04830)

ANALYTE: Folate (Folic acid) (1907)

Test System, Assay, Examination:
    Abbott AxSYM (04532)
    Bayer Immuno 1 System (08123)
    Beckman ACCESS Immunoassay System (07914)
    Boehringer Mannheim Elecsys 2010 Analyzer (07810)

[[Page 51604]]

    Chiron Diagnostics ACS:Centaur (10440)
    Cirrus Diagnostics Immulite 2000 (10418)
    Dade Stratus (13485)
    Dade Stratus II (13486)
    Dade Stratus IIntellect (13487)
    Ortho-Clinical Diagnostics Vitros ECi (46279)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    TOSOH AIA NexIA (auto pretreatment) (61366)
    TOSOH AIA NexIA (manual pretreatment) (61367)

ANALYTE: Folate, Red Blood Cell (RBC Folate) (1930)

Test System, Assay, Examination:
    Bayer Immuno 1 System (with UIW) (08121)
    Beckman ACCESS Immunoassay System (07914)
    Chiron Diagnostics ACS:Centaur (10440)

ANALYTE: Fructosamine (1914)

Test System, Assay, Examination:
    Beckman Synchron CX 4 {RAIChem Fructosamine} (08014)
    Beckman Synchron CX 4 CE {RAIChem Fructosamine} (08015)
    Beckman Synchron CX 5 {RAIChem Fructosamine} (08016)
    Beckman Synchron CX 5 CE {RAIChem Fructosamine} (08017)
    Beckman Synchron CX 7 {RAIChem Fructosamine} (08018)
    Bio-Chem Laboratory Systems ATAC 6000 {RAIChem Fructosamine} 
(08019)
    Chiron Diagnostics 550 Express {RAIChem Fructosamine} (10424)
    Chiron Diagnostics 550 Express Plus {RAIChem Fructosamine} (10425)
    Olympus AU 600 (46229)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)

ANALYTE: Gamma Glutamyl Transferase (GGT) (2201)

Test System, Assay, Examination:
    Abaxis Piccolo Portable Blood Analyzer (04608)
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    HCL Laboratory Systems 200 Biochemistry Analyzer (25266)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Roche Diagnostics Reflotron (55580)
    Roche Diagnostics Reflotron Plus (55582)
    Synermed IR 200 (58460)

ANALYTE: Glucose (2203)

Test System, Assay, Examination:
    AVL OMNI Combi Analyzer (04609)
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    CARESIDE CareSide Analyzer (10445)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Firehouse Medical Safestrip Blood Glucose Test System (19027)
    GDS Diagnostics Stat-Site Meter (22126)
    HCL Laboratory Systems 200 Biochemistry Analyzer (25266)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DT60 Chemistry System (31074)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Nova Stat Profile Ultra L (43124)
    Nova Stat Profile Ultra M (43125)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DT60 (46277)

[[Page 51605]]

    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Radiometer ABL 555 (55277)
    Radiometer ABL 700 Series (55298)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Roche Diagnostics Reflotron (55580)
    Roche Diagnostics Reflotron Plus (55582)
    Synermed IR 200 (58460)

ANALYTE: Glucose, Urine (2225)

Test System, Assay, Examination:
    Boehringer Mannheim Hitachi 747 {STC Auto-Lyte Urine Glucose} 
(07850)
    Roche Diagnostics Hitachi 717 {Chimera UA PERFECT} (55410)
    Roche Diagnostics Hitachi 747 {STC Auto-Lyte Urine Glucose} (55502)

ANALYTE: Glucose-6-Phosphate Dehydrogenase (G-6-PDH) (2208)

Test System, Assay, Examination:
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)

ANALYTE: Glutaraldehyde (2224)

Test System, Assay, Examination:
    Roche Diagnostics Hitachi 717 (55401)

ANALYTE: Glycated Hemoglobin, Total (2221)

Test System, Assay, Examination:
    Bio-Rad VARIANT Express Glycohemoglobin Program (08026)
    Primus CLC 330 (49211)

ANALYTE: Glycosylated Hemoglobin (Hgb A1C) (2204)

Test System, Assay, Examination:
    Beckman Synchron LX System (manual pretreatment) (08079)
    Bio-Rad VARIANT Express Glycohemoglobin Program (08026)
    Bio-Rad VARIANT II (08186)
    Roche Cobas Mira {Roche Unimate HbA1C} (55252)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    TOSOH A1c 2.2 Plus Glycohemoglobin Analyzer (61297)

ANALYTE: HDL Cholesterol (2550)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer {Abbott Direct HDL} (04800)
    Abbott Aeroset {Abbott Direct HDL} (04799)
    Abbott Spectrum {Trace HDL Cholesterol} (auto pretreatment) (04721)
    Abbott Spectrum EPX {Sigma Diagnostics EZ HDL Cholesterol} (04684)
    Abbott Spectrum EPX {Trace HDL Cholesterol} (auto pretreatment) 
(04723)
    Abbott Spectrum Series II {Sigma Diagnostics EZ HDL Cholesterol} 
(04685)
    Abbott Spectrum Series II {Sigma Diagnostics ISOSPIN} (04681)
    Abbott Spectrum Series II {Trace HDL Cholesterol} (auto 
pretreatment) (04722)
    Baxter Paramax {Sigma Diagnostics EZ HDL Cholesterol} (07868)
    Beckman Synchron CX 4 {Genzyme Liquid N-geneous HDL} (07975)
    Beckman Synchron CX 4 {Randox Direct HDL} (08101)
    Beckman Synchron CX 4 {SYNCHRON HDLD} (08210)
    Beckman Synchron CX 4 {Sigma Diagnostics EZ HDL Cholesterol} 
(07841)
    Beckman Synchron CX 4 {Wako Direct HDL-C} (07831)
    Beckman Synchron CX 4 CE {Genzyme Liquid N-geneous HDL} (07974)
    Beckman Synchron CX 4 CE {SYNCHRON HDLD} (08211)
    Beckman Synchron CX 4 DELTA {Genzyme Liquid N-geneous HDL} (07973)
    Beckman Synchron CX 4 DELTA {SYNCHRON HDLD} (08212)
    Beckman Synchron CX 5 {Genzyme Liquid N-geneous HDL} (07972)
    Beckman Synchron CX 5 {RDI LipiDirect HDL} (08093)
    Beckman Synchron CX 5 {Randox Direct HDL} (08102)
    Beckman Synchron CX 5 {SYNCHRON HDLD} (08213)
    Beckman Synchron CX 5 {Sigma Diagnostics EZ HDL Cholesterol} 
(07842)
    Beckman Synchron CX 5 {Trace HDL Cholesterol} (auto pretreatment) 
(07864)
    Beckman Synchron CX 5 {Wako Direct HDL-C} (07832)
    Beckman Synchron CX 5 CE {Genzyme Liquid N-geneous HDL} (07971)
    Beckman Synchron CX 5 CE {SYNCHRON HDLD} (08214)
    Beckman Synchron CX 5 DELTA {Genzyme Liquid N-geneous HDL} (07970)
    Beckman Synchron CX 5 DELTA {SYNCHRON HDLD} (08215)
    Beckman Synchron CX 7 {Genzyme Liquid N-geneous HDL} (07969)
    Beckman Synchron CX 7 {RDI LipiDirect HDL} (08094)
    Beckman Synchron CX 7 {Randox Direct HDL} (08103)
    Beckman Synchron CX 7 {SYNCHRON HDLD} (08216)
    Beckman Synchron CX 7 {Sigma Diagnostics EZ HDL Cholesterol} 
(07843)
    Beckman Synchron CX 7 {Trace HDL Cholesterol} (auto pretreatment) 
(07865)
    Beckman Synchron CX 7 {Wako Direct HDL-C} (07833)
    Beckman Synchron CX 7 DELTA {Genzyme Liquid N-geneous HDL} (07968)
    Beckman Synchron CX 7 DELTA {RDI LipiDirect HDL} (08195)
    Beckman Synchron CX 7 DELTA {SYNCHRON HDLD} (08217)
    Beckman Synchron CX 9 ALX {Genzyme Liquid N-geneous HDL} (07967)
    Beckman Synchron CX 9 ALX System {SYNCHRON HDLD} (08218)
    Beckman Synchron LX System {DMA One Shots} (08082)
    Beckman Synchron LX System {Genzyme Liquid N-geneous HDL} (08083)
    Beckman Synchron LX System {MHS SPINPRO} (08084)
    Beckman Synchron LX System {RDI Unitized Magnetic HDL} (08085)
    Beckman Synchron LX System {SYNCHRON HDLD} (08219)
    Beckman Synchron LX System {Sigma Diagnostics EZ HDL

[[Page 51606]]

Cholesterol} (08086)
    Beckman Synchron LX System {Trace America Singles} (08087)
    Beckman Synchron LX System {Trace HDL Cholesterol} (auto 
pretreatment) (08088)
    Beckman Synchron LX System {Wako Direct HDL-C} (08089)
    Bio-Chem Laboratory Systems ATAC 6000 {Elan Diagnostics Direct HDL} 
(08208)
    Bio-Chem Laboratory Systems ATAC 8000 {Elan Diagnostics Direct HDL} 
(08207)
    Boehringer Mannheim Hitachi 704 {Randox Direct HDL} (07997)
    Boehringer Mannheim Hitachi 704 {Sigma Diagnostics EZ HDL 
Cholesterol} (07844)
    Boehringer Mannheim Hitachi 704 {Wako Direct HDL-C} (07834)
    Boehringer Mannheim Hitachi 705 {Wako Direct HDL-C} (07835)
    Boehringer Mannheim Hitachi 717 {EQual HDL Direct} (07926)
    Boehringer Mannheim Hitachi 717 {Genzyme Liquid N-geneous HDL} 
(07979)
    Boehringer Mannheim Hitachi 717 {Randox Direct HDL} (07998)
    Boehringer Mannheim Hitachi 717 {Sigma Diagnostics EZ HDL 
Cholesterol} (07845)
    Boehringer Mannheim Hitachi 717 {Trace HDL Cholesterol} (auto 
pretreatment) (07866)
    Boehringer Mannheim Hitachi 717 {Wako Direct HDL-C} (07836)
    Boehringer Mannheim Hitachi 736 {Genzyme Liquid N-geneous HDL} 
(07978)
    Boehringer Mannheim Hitachi 736 {Sigma Diagnostics EZ HDL 
Cholesterol} (07846)
    Boehringer Mannheim Hitachi 737 {Randox Direct HDL} (08098)
    Boehringer Mannheim Hitachi 737 {Sigma Diagnostics EZ HDL 
Cholesterol} (07847)
    Boehringer Mannheim Hitachi 747 {Genzyme Liquid N-geneous HDL} 
(07980)
    Boehringer Mannheim Hitachi 747 {RDI LipiDirect HDL} (08090)
    Boehringer Mannheim Hitachi 747 {Randox Direct HDL} (07999)
    Boehringer Mannheim Hitachi 747 {Sigma Diagnostics EZ HDL 
Cholesterol} (07848)
    Boehringer Mannheim Hitachi 747 {Trace HDL Cholesterol} (auto 
pretreatment) (07867)
    Boehringer Mannheim Hitachi 747 {Wako Direct HDL-C} (07837)
    Boehringer Mannheim Hitachi 911 {Genzyme Liquid N-geneous HDL} 
(07977)
    Boehringer Mannheim Hitachi 911 {RDI LipiDirect HDL} (08091)
    Boehringer Mannheim Hitachi 911 {Randox Direct HDL} (08000)
    Boehringer Mannheim Hitachi 911 {Sigma Diagnostics EZ HDL 
Cholesterol} (07849)
    Boehringer Mannheim Hitachi 911 {Wako Direct HDL-C} (07838)
    Boehringer Mannheim Hitachi 914 {Randox Direct HDL} (08001)
    Boehringer Mannheim Hitachi 917 {Genzyme Liquid N-geneous HDL} 
(07976)
    Boehringer Mannheim Hitachi 917 {RDI LipiDirect HDL} (08092)
    Boehringer Mannheim Hitachi 917 {Randox Direct HDL} (08002)
    Boehringer Mannheim Hitachi 917 {Sigma Diagnostics EZ HDL 
Cholesterol} (07869)
    Boehringer Mannheim Hitachi 917 {Wako Direct HDL-C} (07839)
    CARESIDE CareSide Analyzer (10445)
    Chiron Diagnostics 550 Express {Genzyme Liquid N-geneous HDL} 
(10452)
    Chiron Diagnostics 550 Express {RDI LipiDirect HDL} (10468)
    Chiron Diagnostics 550 Express Plus {Genzyme Liquid N-geneous HDL} 
(10451)
    Ciba Corning 550 Express {Sigma Diagnostics EZ HDL Cholesterol} 
(10391)
    Ciba Corning 550 Express {Trace HDL Cholesterol} (auto 
pretreatment) (10400)
    Ciba Corning 550 Express Plus {Trace HDL Cholesterol} (auto 
pretreatment) (10401)
    Coulter Optichem 120 {Sigma Diagnostics ISOSPIN} (10448)
    Dade Behring Dimension AR {Dimension AHDL} (13545)
    Dade Behring Dimension AR {Sigma Diagnostics EZ HDL Cholesterol} 
(13518)
    Dade Behring Dimension RxL {Dimension AHDL} (13546)
    Dade Behring Dimension RxL {RDI LipiDirect HDL} (13520)
    Dade Behring aca IV {DMA One Shots} (13529)
    Dade Behring aca IV {MHS SPINPRO} (13530)
    Dade Dimension {Trace HDL Cholesterol} (auto pretreatment) (13444)
    Dade Dimension AR {Sigma Diagnostics EZ HDL Cholesterol} (13445)
    Dade Dimension ES {RDI LipiDirect HDL} (13484)
    Dade Dimension RxL {RDI LipiDirect HDL} (13483)
    Dade Dimension XL {Dimension AHDL} (13547)
    Dade Dimension XL {Genzyme Liquid N-geneous HDL} (13467)
    Instrumentation Laboratory IL Monarch {Sigma Diagnostics EZ HDL 
Cholesterol} (28476)
    Instrumentation Laboratory IL Monarch {Trace HDL Cholesterol} (auto 
pretreatment) (28480)
    Instrumentation Laboratory ILAB 1800 {Sigma Diagnostics EZ HDL 
Cholesterol} (28475)
    Instrumentation Laboratory ILAB 1800 {Wako Direct HDL-C} (28471)
    Instrumentation Laboratory ILAB 900 {Sigma Diagnostics EZ HDL 
Cholesterol} (28474)
    Instrumentation Laboratory ILAB 900 {Wako Direct HDL-C} (28470)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DT60 Chemistry System (31074)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 5000 {Sigma Diagnostics EZ HDL Cholesterol} (46231)
    Olympus AU 5200 {Genzyme Liquid N-geneous HDL} (46250)
    Olympus AU 5200 {RDI LipiDirect HDL} (46320)
    Olympus AU 5200 {Sigma Diagnostics EZ HDL Cholesterol} (46232)
    Olympus AU 5200 {Wako Direct HDL-C} (46227)
    Olympus AU 600 {Genzyme Liquid N-geneous HDL} (46291)
    Olympus AU 600 {RDI LipiDirect HDL} (46318)
    Olympus AU 600 {Sigma Diagnostics EZ HDL Cholesterol} (46239)
    Olympus AU 800 {Genzyme Liquid N-geneous HDL} (46249)
    Olympus AU 800 {RDI LipiDirect HDL} (46319)
    Olympus AU 800 {Sigma Diagnostics EZ HDL Cholesterol} (46233)
    Olympus AU 800 {Wako Direct HDL-C} (46226)
    Olympus Reply {Sigma Diagnostics EZ HDL Cholesterol} (46234)
    Olympus Reply {Wako Direct HDL-C} (46228)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)

[[Page 51607]]

    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DT60 (46277)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Cobas Bio {Sigma Diagnostics EZ HDL Cholesterol} (55226)
    Roche Cobas Bio {Wako Direct HDL-C} (55220)
    Roche Cobas FARA {RDI LipiDirect HDL} (55617)
    Roche Cobas FARA {Sigma Diagnostics EZ HDL Cholesterol} (55227)
    Roche Cobas FARA {Wako Direct HDL-C} (55221)
    Roche Cobas FARA II {Sigma Diagnostics EZ HDL Cholesterol} (55228)
    Roche Cobas FARA II {Wako Direct HDL-C} (55222)
    Roche Cobas INTEGRA {COBAS INTEGRA HDL-Cholesterol Direct} (55292)
    Roche Cobas Mira {EQual HDL Direct} (55247)
    Roche Cobas Mira {Genzyme Liquid N-geneous HDL} (55260)
    Roche Cobas Mira {RDI LipiDirect HDL} (55289)
    Roche Cobas Mira {Randox Direct HDL} (55293)
    Roche Cobas Mira {Roche Unimate HDL Direct} (55243)
    Roche Cobas Mira {Sigma Diagnostics EZ HDL Cholesterol} (55225)
    Roche Cobas Mira {Trace HDL Cholesterol} (auto pretreatment) 
(55234)
    Roche Cobas Mira {Wako Direct HDL-C} (55223)
    Roche Cobas Mira Plus {RDI LipiDirect HDL} (55290)
    Roche Cobas Mira Plus {Randox Direct HDL} (55295)
    Roche Cobas Mira Plus {Roche Unimate HDL Direct} (55245)
    Roche Cobas Mira Plus {Wako Direct HDL-C} (55224)
    Roche Cobas Mira S {RDI LipiDirect HDL} (55291)
    Roche Cobas Mira S {Randox Direct HDL} (55294)
    Roche Cobas Mira S {Roche Unimate HDL Direct} (55244)
    Roche Diagnostics Hitachi 704 {DMA One Shots} (55380)
    Roche Diagnostics Hitachi 704 {MHS SPINPRO} (55389)
    Roche Diagnostics Hitachi 704 {RDI Unitized Magnetic HDL} (55391)
    Roche Diagnostics Hitachi 704 {Randox Direct HDL} (55394)
    Roche Diagnostics Hitachi 704 {Roche Direct HDL} (55371)
    Roche Diagnostics Hitachi 704 {Sigma Diagnostics EZ HDL 
Cholesterol} (55396)
    Roche Diagnostics Hitachi 704 {Sigma Diagnostics ISOSPIN} (55397)
    Roche Diagnostics Hitachi 704 {Trace America Singles} (55398)
    Roche Diagnostics Hitachi 704 {Wako Direct HDL-C} (55399)
    Roche Diagnostics Hitachi 717 {DMA One Shots} (55426)
    Roche Diagnostics Hitachi 717 {EQual HDL Direct} (55432)
    Roche Diagnostics Hitachi 717 {Genzyme Liquid N-geneous HDL} 
(55434)
    Roche Diagnostics Hitachi 717 {Genzyme N-geneous HDL} (55435)
    Roche Diagnostics Hitachi 717 {MHS SPINPRO} (55438)
    Roche Diagnostics Hitachi 717 {RDI LipiDirect HDL} (55618)
    Roche Diagnostics Hitachi 717 {RDI Unitized Magnetic HDL} (55440)
    Roche Diagnostics Hitachi 717 {Randox Direct HDL} (55443)
    Roche Diagnostics Hitachi 717 {Roche Direct HDL} (55405)
    Roche Diagnostics Hitachi 717 {Sigma Diagnostics EZ HDL 
Cholesterol} (55445)
    Roche Diagnostics Hitachi 717 {Sigma Diagnostics ISOSPIN} (55446)
    Roche Diagnostics Hitachi 717 {Trace America Singles} (55447)
    Roche Diagnostics Hitachi 717 {Trace HDL Cholesterol} (auto 
pretreatment) (55448)
    Roche Diagnostics Hitachi 717 {Wako Direct HDL-C} (55449)
    Roche Diagnostics Hitachi 736 {DMA One Shots} (55452)
    Roche Diagnostics Hitachi 736 {Genzyme Liquid N-geneous HDL} 
(55453)
    Roche Diagnostics Hitachi 736 {Genzyme N-geneous HDL} (55454)
    Roche Diagnostics Hitachi 736 {MHS SPINPRO} (55457)
    Roche Diagnostics Hitachi 736 {RDI Unitized Magnetic HDL} (55459)
    Roche Diagnostics Hitachi 736 {Sigma Diagnostics EZ HDL 
Cholesterol} (55461)
    Roche Diagnostics Hitachi 736 {Sigma Diagnostics ISOSPIN} (55462)
    Roche Diagnostics Hitachi 736 {Trace America Singles} (55463)
    Roche Diagnostics Hitachi 737 {DMA One Shots} (55468)
    Roche Diagnostics Hitachi 737 {MHS SPINPRO} (55472)
    Roche Diagnostics Hitachi 737 {RDI Unitized Magnetic HDL} (55474)
    Roche Diagnostics Hitachi 737 {Randox Direct HDL-Cholesterol} 
(55476)
    Roche Diagnostics Hitachi 737 {Sigma Diagnostics EZ HDL 
Cholesterol} (55477)
    Roche Diagnostics Hitachi 737 {Sigma Diagnostics ISOSPIN} (55478)
    Roche Diagnostics Hitachi 737 {Trace America Singles} (55479)
    Roche Diagnostics Hitachi 747 {DMA One Shots} (55485)
    Roche Diagnostics Hitachi 747 {Genzyme Liquid N-geneous HDL} 
(55491)
    Roche Diagnostics Hitachi 747 {Genzyme N-geneous HDL} (55492)
    Roche Diagnostics Hitachi 747 {MHS SPINPRO} (55495)
    Roche Diagnostics Hitachi 747 {RDI LipiDirect HDL} (55496)
    Roche Diagnostics Hitachi 747 {RDI Unitized Magnetic HDL} (55498)
    Roche Diagnostics Hitachi 747 {Randox Direct HDL} (55501)
    Roche Diagnostics Hitachi 747 {Roche Direct HDL} (55482)
    Roche Diagnostics Hitachi 747 {Sigma Diagnostics EZ HDL 
Cholesterol} (55506)
    Roche Diagnostics Hitachi 747 {Sigma Diagnostics ISOSPIN} (55507)
    Roche Diagnostics Hitachi 747 {Trace America Singles} (55508)
    Roche Diagnostics Hitachi 747 {Trace HDL Cholesterol} (auto 
pretreatment) (55509)
    Roche Diagnostics Hitachi 747 {Wako Direct HDL-C} (55510)
    Roche Diagnostics Hitachi 902 {Roche Direct HDL} (55601)
    Roche Diagnostics Hitachi 911 {Genzyme Liquid N-geneous HDL} 
(55529)
    Roche Diagnostics Hitachi 911 {Genzyme N-geneous HDL} (55530)
    Roche Diagnostics Hitachi 911 {MHS SPINPRO} (55533)
    Roche Diagnostics Hitachi 911 {RDI LipiDirect HDL} (55534)
    Roche Diagnostics Hitachi 911 {RDI Unitized Magnetic HDL} (55536)
    Roche Diagnostics Hitachi 911 {Randox Direct HDL} (55539)
    Roche Diagnostics Hitachi 911 {Roche Direct HDL} (55517)
    Roche Diagnostics Hitachi 911 {Sigma Diagnostics EZ HDL 
Cholesterol} (55541)
    Roche Diagnostics Hitachi 911 {Sigma Diagnostics ISOSPIN} (55542)
    Roche Diagnostics Hitachi 911 {Wako Direct HDL-C} (55543)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 {RDI Unitized Magnetic HDL} (55557)
    Roche Diagnostics Hitachi 914 {Randox Direct HDL} (55559)
    Roche Diagnostics Hitachi 914 {Roche Direct HDL} (55552)
    Roche Diagnostics Hitachi 917 {Genzyme Liquid N-geneous HDL} 
(55569)
    Roche Diagnostics Hitachi 917

[[Page 51608]]

{Genzyme N-geneous HDL} (55570)
    Roche Diagnostics Hitachi 917 {RDI LipiDirect HDL} (55572)
    Roche Diagnostics Hitachi 917 {Randox Direct HDL} (55573)
    Roche Diagnostics Hitachi 917 {Roche Direct HDL} (55563)
    Roche Diagnostics Hitachi 917 {Sigma Diagnostics EZ HDL 
Cholesterol} (55574)
    Roche Diagnostics Hitachi 917 {Wako Direct HDL-C} (55575)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Roche Diagnostics Reflotron (55580)
    Roche Diagnostics Reflotron Plus (55582)
    Schiapparelli Biosystems ACE {Trace HDL Cholesterol} (auto 
pretreatment) (58444)
    Technicon AXON {Sigma Diagnostics EZ HDL Cholesterol} (61270)
    Technicon AXON {Wako Direct HDL-C} (61264)
    Technicon DAX {Sigma Diagnostics EZ HDL Cholesterol} (61271)
    Technicon DAX 24 {Wako Direct HDL-C} (61265)
    Technicon DAX 48 {Wako Direct HDL-C} (61266)
    Technicon DAX 72 {Wako Direct HDL-C} (61267)
    Technicon DAX 96 {Wako Direct HDL-C} (61268)
    Technicon RA 1000 {Sigma Diagnostics EZ HDL Cholesterol} (61273)
    Technicon RA 1000 {Trace HDL Cholesterol} (auto pretreatment) 
(61284)
    Technicon RA 500 {Sigma Diagnostics EZ HDL Cholesterol} (61272)
    Technicon RA 500 {Trace HDL Cholesterol} (auto pretreatment) 
(61285)
    Technicon RA XT {Sigma Diagnostics EZ HDL Cholesterol} (61274)
    Technicon RA XT {Trace HDL Cholesterol} (auto pretreatment) (61286)
    Technicon opeRA {Sigma Diagnostics EZ HDL Cholesterol} (61275)
    Wako Diagnostics 30R {Sigma Diagnostics EZ HDL Cholesterol} (70193)
    Wako Diagnostics 30R {Wako Direct HDL-C} (70192)

ANALYTE: Haptoglobin (2511)

Test System, Assay, Examination:
    Beckman QM 300 Protein System (07915)
    Boehringer Mannheim Hitachi 717 {Crestat N-Assay TIA Haptoglobin} 
(08036)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 717 {Crestat N-Assay TIA Haptoglobin} 
(55420)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 912 (55624)

ANALYTE: Hemoglobin F (2516)

Test System, Assay, Examination:
    Radiometer ABL System 620 (55229)

ANALYTE: Hemoglobin S (2536)

Test System, Assay, Examination:
    Medicus Technologies SICKLE-2000 (40309)

ANALYTE: Homocysteine (2574)

Test System, Assay, Examination:
    Abbott IMX (04056)

ANALYTE: Iron (2814)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)

ANALYTE: Iron Binding Capacity, Unsat. (UIBC) no pretreat. (2823)

Test System, Assay, Examination:
    Abbott Aeroset (04798)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Dade Behring Dimension AR (13517)
    Dade Dimension XL (13422)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Olympus Reply/AU560 (46129)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Technicon AXON (61001)
    Wako Diagnostics 30R (70002)

ANALYTE: Ketone, Urine (3404)

Test System, Assay, Examination:
    Roche Diagnostics Hitachi 717 {Chimera UA PERFECT} (55410)

NALYTE: LDL Cholesterol (3748)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Abbott Aeroset {Wako L-Type LDL-C} (04801)
    Abbott EPX {RDI Unitized LipiDirect

[[Page 51609]]

Magnetic LDL} (04760)
    Abbott Series II {RDI Unitized LipiDirect Magnetic LDL} (04761)
    Abbott Spectrum {DMA One Shots} (04598)
    Abbott Spectrum {RDI Unitized LipiDirect Magnetic LDL} (04759)
    Abbott Spectrum {RDI Unitized Precipitating Reagent} (04749)
    Abbott Spectrum EPX {DMA One Shots} (04600)
    Abbott Spectrum EPX {RDI Unitized Precipitating Reagent} (04750)
    Abbott Spectrum Series II {DMA One Shots} (04601)
    Abbott Spectrum Series II {RDI Unitized Precipitating Reagent} 
(04751)
    Abbott Spectrum Series II {Sigma Diagnostics EZ LDL} (04817)
    Abbott VP {DMA One Shots} (auto calculations) (04756)
    Abbott VP {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (04763)
    Abbott VP {RDI Unitized Precipitating Reagent} (auto calculations) 
(04754)
    Baxter Paramax {Sigma Diagnostics EZ LDL} (08185)
    Beckman Synchron CX 4 {Genzyme N-geneous LDL} (07940)
    Beckman Synchron CX 4 {Sigma Diagnostics EZ LDL} (08173)
    Beckman Synchron CX 4 {Wako L-Type LDL-C} (08135)
    Beckman Synchron CX 4 CE {Genzyme N-geneous LDL} (07943)
    Beckman Synchron CX 4 DELTA {Genzyme N-geneous LDL} (07945)
    Beckman Synchron CX 5 {Genzyme N-geneous LDL} (07941)
    Beckman Synchron CX 5 {Sigma Diagnostics EZ LDL} (08174)
    Beckman Synchron CX 5 {Wako L-Type LDL-C} (08136)
    Beckman Synchron CX 5 CE {Genzyme N-geneous LDL} (07944)
    Beckman Synchron CX 5 DELTA {Genzyme N-geneous LDL} (07946)
    Beckman Synchron CX 7 {Genzyme N-geneous LDL} (07942)
    Beckman Synchron CX 7 {RDI Direct LDL} (08194)
    Beckman Synchron CX 7 {Sigma Diagnostics EZ LDL} (08175)
    Beckman Synchron CX 7 {Wako L-Type LDL-C} (08137)
    Beckman Synchron CX 7 DELTA {Genzyme N-geneous LDL} (07947)
    Beckman Synchron CX 9 ALX System {Genzyme N-geneous LDL} (07948)
    Beckman Synchron CX Systems {DMA One Shots} (07996)
    Beckman Synchron CX Systems {RDI Unitized LipiDirect Magnetic LDL} 
(08011)
    Beckman Synchron CX Systems {RDI Unitized Precipitating Reagent} 
(07990)
    Beckman Synchron LX System {Sigma Diagnostics EZ LDL} (08176)
    Boehringer Mannheim Hitachi 704 {DMA One Shots} (07627)
    Boehringer Mannheim Hitachi 704 {RDI Unitized LipiDirect Magnetic 
LDL} (08003)
    Boehringer Mannheim Hitachi 704 {RDI Unitized Precipitating 
Reagent} (07982)
    Boehringer Mannheim Hitachi 704 {Sigma Diagnostics EZ LDL} (08182)
    Boehringer Mannheim Hitachi 704 {Wako L-Type LDL-C} (08130)
    Boehringer Mannheim Hitachi 705 {DMA One Shots} (07628)
    Boehringer Mannheim Hitachi 705 {RDI Unitized LipiDirect Magnetic 
LDL} (08004)
    Boehringer Mannheim Hitachi 705 {RDI Unitized Precipitating 
Reagent} (07983)
    Boehringer Mannheim Hitachi 717 {DMA One Shots} (07629)
    Boehringer Mannheim Hitachi 717 {Genzyme N-geneous LDL} (07936)
    Boehringer Mannheim Hitachi 717 {RDI Unitized LipiDirect Magnetic 
LDL} (08005)
    Boehringer Mannheim Hitachi 717 {RDI Unitized Precipitating 
Reagent} (07984)
    Boehringer Mannheim Hitachi 717 {Sigma Diagnostics EZ LDL} (08177)
    Boehringer Mannheim Hitachi 717 {Wako L-Type LDL-C} (08131)
    Boehringer Mannheim Hitachi 736 {DMA One Shots} (07630)
    Boehringer Mannheim Hitachi 736 {Genzyme N-geneous LDL} (07937)
    Boehringer Mannheim Hitachi 736 {RDI Unitized LipiDirect Magnetic 
LDL} (08006)
    Boehringer Mannheim Hitachi 736 {RDI Unitized Precipitating 
Reagent} (07985)
    Boehringer Mannheim Hitachi 736 {Sigma Diagnostics EZ LDL} (08183)
    Boehringer Mannheim Hitachi 737 {DMA One Shots} (07631)
    Boehringer Mannheim Hitachi 737 {RDI Unitized LipiDirect Magnetic 
LDL} (08007)
    Boehringer Mannheim Hitachi 737 {RDI Unitized Precipitating 
Reagent} (07986)
    Boehringer Mannheim Hitachi 737 {Sigma Diagnostics EZ LDL} (08184)
    Boehringer Mannheim Hitachi 747 {DMA One Shots} (07632)
    Boehringer Mannheim Hitachi 747 {Genzyme N-geneous LDL} (07935)
    Boehringer Mannheim Hitachi 747 {RDI Unitized LipiDirect Magnetic 
LDL} (08008)
    Boehringer Mannheim Hitachi 747 {RDI Unitized Precipitating 
Reagent} (07987)
    Boehringer Mannheim Hitachi 747 {Sigma Diagnostics EZ LDL} (08178)
    Boehringer Mannheim Hitachi 747 {Wako L-Type LDL-C} (08132)
    Boehringer Mannheim Hitachi 911 {DMA One Shots} (07994)
    Boehringer Mannheim Hitachi 911 {Genzyme N-geneous LDL} (07939)
    Boehringer Mannheim Hitachi 911 {RDI Unitized LipiDirect Magnetic 
LDL} (08009)
    Boehringer Mannheim Hitachi 911 {RDI Unitized Precipitating 
Reagent} (07988)
    Boehringer Mannheim Hitachi 911 {Sigma Diagnostics EZ LDL} (08179)
    Boehringer Mannheim Hitachi 911 {Wako L-Type LDL-C} (08133)
    Boehringer Mannheim Hitachi 912 {Sigma Diagnostics EZ LDL} (08180)
    Boehringer Mannheim Hitachi 914 {DMA One Shots} (07995)
    Boehringer Mannheim Hitachi 914 {RDI Unitized LipiDirect Magnetic 
LDL} (08010)
    Boehringer Mannheim Hitachi 914 {RDI Unitized Precipitating 
Reagent} (07989)
    Boehringer Mannheim Hitachi 917 {Genzyme N-geneous LDL} (07938)
    Boehringer Mannheim Hitachi 917 {Sigma Diagnostics EZ LDL} (08181)
    Boehringer Mannheim Hitachi 917 {Wako L-Type LDL-C} (08134)
    Chiron Diagnostics 550 Express {DMA One Shots} (10353)
    Chiron Diagnostics 550 Express {Genzyme N-geneous LDL} (10449)
    Chiron Diagnostics 550 Express {RDI Direct LDL} (10467)
    Chiron Diagnostics 550 Express {RDI Unitized LipiDirect Magnetic 
LDL} (10421)
    Chiron Diagnostics 550 Express {RDI Unitized Precipitating Reagent} 
(10414)
    Chiron Diagnostics 550 Express {Sigma Diagnostics EZ LDL} (10463)
    Chiron Diagnostics 550 Express {Wako L-Type LDL-C} (10453)
    Chiron Diagnostics 550 Express Plus {Genzyme N-geneous LDL} (10450)
    Coulter Optichem {DMA One Shots} (auto calculations) (10420)
    Coulter Optichem {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (10423)
    Coulter Optichem {RDI Unitized Precipitating Reagent} (auto 
calculations) (10417)

[[Page 51610]]

    Dade Behring Dimension AR {Sigma Diagnostics EZ LDL} (13550)
    Dade Behring Dimension RxL {Sigma Diagnostics EZ LDL} (13552)
    Dade Dimension {DMA One Shots} (auto calculations) (13471)
    Dade Dimension {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (13473)
    Dade Dimension {RDI Unitized Precipitating Reagent} (auto 
calculations) (13469)
    Dade Dimension XL {Genzyme N-geneous LDL} (13531)
    Dade Dimension XL {Sigma Diagnostics EZ LDL} (13551)
    EM Diagnostic Systems EPOS {DMA One Shots} (auto calculations) 
(16171)
    EM Diagnostic Systems EPOS {RDI Unitized LipiDirect Magnetic LDL} 
(auto calculations) (16179)
    EM Diagnostic Systems EPOS {RDI Unitized Precipitating Reagent} 
(auto calculations) (16163)
    Electronucleonics Gemini {DMA One Shots} (auto calculations) 
(16165)
    Electronucleonics Gemini {RDI Unitized LipiDirect Magnetic LDL} 
(auto calculations) (16173)
    Electronucleonics Gemini {RDI Unitized Precipitating Reagent} (auto 
calculations) (16157)
    Electronucleonics Gemprofiler {DMA One Shots} (auto calculations) 
(16167)
    Electronucleonics Gemprofiler {RDI Unitized LipiDirect Magnetic 
LDL} (auto calculations) (16175)
    Electronucleonics Gemprofiler {RDI Unitized Precipitating Reagent} 
(auto calculations) (16159)
    Electronucleonics Gemstar {DMA One Shots} (auto calculations) 
(16169)
    Electronucleonics Gemstar {RDI Unitized LipiDirect Magnetic LDL} 
(auto calculations) (16177)
    Electronucleonics Gemstar {RDI Unitized Precipitating Reagent} 
(auto calculations) (16161)
    Instrumentation Laboratory IL Genesis 21 {DMA One Shots} (auto 
calculations) (28503)
    Instrumentation Laboratory IL Genesis 21 {RDI Unitized LipiDirect 
Magnetic LDL} (auto calculations) (28507)
    Instrumentation Laboratory IL Genesis 21 {RDI Unitized 
Precipitating Reagent} (auto calculations) (28498)
    Instrumentation Laboratory IL Monarch (auto calculations) (28496)
    Instrumentation Laboratory IL Monarch {DMA One Shots} (auto 
calculations) (28501)
    Instrumentation Laboratory IL Monarch {RDI Unitized LipiDirect 
Magnetic LDL} (auto calculations) (28505)
    Instrumentation Laboratory ILAB 1800 {Sigma Diagnostics EZ LDL} 
(28557)
    Instrumentation Laboratory ILAB 1800 {Wako L-Type LDL-C} (28535)
    Instrumentation Laboratory ILAB 900 {Sigma Diagnostics EZ LDL} 
(28556)
    Instrumentation Laboratory ILAB 900 {Wako L-Type LDL-C} (28534)
    Johnson & Johnson Vitros {DMA One Shots} (auto calculations) 
(31080)
    Johnson & Johnson Vitros {RDI Unitized LipiDirect Magnetic LDL} 
(auto calculations) (31082)
    Johnson & Johnson Vitros {RDI Unitized Precipitating Reagent} (auto 
calculations) (31078)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 {Wako L-Type LDL-C} (46294)
    Olympus AU 5200 {DMA One Shots} (46180)
    Olympus AU 5200 {RDI Unitized LipiDirect Magnetic LDL} (46262)
    Olympus AU 5200 {RDI Unitized Precipitating Reagent} (46252)
    Olympus AU 5200 {Sigma Diagnostics EZ LDL} (46310)
    Olympus AU 5200 {Wako L-Type LDL-C} (46295)
    Olympus AU 600 {RDI Direct LDL} (46317)
    Olympus AU 600 {Sigma Diagnostics EZ LDL} (46312)
    Olympus AU 800 {DMA One Shots} (46185)
    Olympus AU 800 {RDI Unitized LipiDirect Magnetic LDL} (46261)
    Olympus AU 800 {RDI Unitized Precipitating Reagent} (46251)
    Olympus AU 800 {Sigma Diagnostics EZ LDL} (46311)
    Olympus AU 800 {Wako L-Type LDL-C} (46293)
    Olympus Demand {DMA One Shots} (auto calculations) (46258)
    Olympus Demand {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (46264)
    Olympus Demand {RDI Unitized Precipitating Reagent} (auto 
calculations) (46254)
    Olympus Reply {DMA One Shots} (auto calculations) (46260)
    Olympus Reply {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (46266)
    Olympus Reply {RDI Unitized Precipitating Reagent} (auto 
calculations) (46256)
    Olympus Reply {Wako L-Type LDL-C} (46296)
    Ortho-Clinical Diagnostics Vitros {DMA One Shots} (auto 
calculations) (46282)
    Ortho-Clinical Diagnostics Vitros {RDI Unitized LipiDirect Magnetic 
LDL} (auto calculations) (46284)
    Ortho-Clinical Diagnostics Vitros {RDI Unitized Precipitating 
Reagent} (auto calculations) (46280)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Cobas Bio {DMA One Shots} (auto calculations) (55268)
    Roche Cobas Bio {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (55274)
    Roche Cobas Bio {RDI Unitized Precipitating Reagent} (auto 
calculations) (55264)
    Roche Cobas Bio {Sigma Diagnostics EZ LDL} (55594)
    Roche Cobas FARA {DMA One Shots} (auto calculations) (55270)
    Roche Cobas FARA {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (55276)
    Roche Cobas FARA {RDI Unitized Precipitating Reagent} (auto 
calculations) (55266)
    Roche Cobas FARA {Sigma Diagnostics EZ LDL} (55590)
    Roche Cobas FARA {Wako L-Type LDL-C} (55306)
    Roche Cobas FARA II {Sigma Diagnostics EZ LDL} (55595)
    Roche Cobas INTEGRA (55179)
    Roche Cobas Mira {DMA One Shots} (55155)
    Roche Cobas Mira {Genzyme N-geneous LDL} (55254)
    Roche Cobas Mira {RDI Direct LDL} (55613)
    Roche Cobas Mira {RDI Unitized LipiDirect Magnetic LDL} (55272)
    Roche Cobas Mira {RDI Unitized Precipitating Reagent} (55262)
    Roche Cobas Mira {Sigma Diagnostics EZ LDL} (55591)
    Roche Cobas Mira {Wako L-Type LDL-C} (55304)
    Roche Cobas Mira Plus {Sigma Diagnostics EZ LDL} (55593)
    Roche Cobas Mira Plus {Wako L-Type LDL-C} (55305)
    Roche Cobas Mira S {Sigma Diagnostics EZ LDL} (55592)
    Roche Diagnostics Hitachi 704 {DMA One Shots} (55380)
    Roche Diagnostics Hitachi 704 {Genzyme immunoseparation tube} 
(55388)
    Roche Diagnostics Hitachi 704 {RDI Unitized LipiDirect Magnetic 
LDL} (55390)
    Roche Diagnostics Hitachi 704 {RDI Unitized Precipitating Reagent} 
(55392)
    Roche Diagnostics Hitachi 704 {Wako L-Type LDL-C} (55400)
    Roche Diagnostics Hitachi 717 {DMA One Shots} (55426)
    Roche Diagnostics Hitachi 717 {Genzyme N-geneous LDL} (55436)

[[Page 51611]]

    Roche Diagnostics Hitachi 717 {Genzyme immunoseparation tube} 
(55437)
    Roche Diagnostics Hitachi 717 {RDI Direct LDL} (55614)
    Roche Diagnostics Hitachi 717 {RDI Unitized LipiDirect Magnetic 
LDL} (55439)
    Roche Diagnostics Hitachi 717 {RDI Unitized Precipitating Reagent} 
(55441)
    Roche Diagnostics Hitachi 717 {Wako L-Type LDL-C} (55450)
    Roche Diagnostics Hitachi 736 {DMA One Shots} (55452)
    Roche Diagnostics Hitachi 736 {Genzyme N-geneous LDL} (55455)
    Roche Diagnostics Hitachi 736 {Genzyme immunoseparation tube} 
(55456)
    Roche Diagnostics Hitachi 736 {RDI Unitized LipiDirect Magnetic 
LDL} (55458)
    Roche Diagnostics Hitachi 736 {RDI Unitized Precipitating Reagent} 
(55460)
    Roche Diagnostics Hitachi 737 {DMA One Shots} (55468)
    Roche Diagnostics Hitachi 737 {Genzyme immunoseparation tube} 
(55471)
    Roche Diagnostics Hitachi 737 {RDI Unitized LipiDirect Magnetic 
LDL} (55473)
    Roche Diagnostics Hitachi 737 {RDI Unitized Precipitating Reagent} 
(55475)
    Roche Diagnostics Hitachi 747 {DMA One Shots} (55485)
    Roche Diagnostics Hitachi 747 {Genzyme N-geneous LDL} (55493)
    Roche Diagnostics Hitachi 747 {Genzyme immunoseparation tube} 
(55494)
    Roche Diagnostics Hitachi 747 {RDI Unitized LipiDirect Magnetic 
LDL} (55497)
    Roche Diagnostics Hitachi 747 {RDI Unitized Precipitating Reagent} 
(55499)
    Roche Diagnostics Hitachi 747 {Wako L-Type LDL-C} (55511)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 {DMA One Shots} (55522)
    Roche Diagnostics Hitachi 911 {Genzyme N-geneous LDL} (55531)
    Roche Diagnostics Hitachi 911 {Genzyme immunoseparation tube} 
(55532)
    Roche Diagnostics Hitachi 911 {RDI Direct LDL} (55615)
    Roche Diagnostics Hitachi 911 {RDI Unitized LipiDirect Magnetic 
LDL} (55535)
    Roche Diagnostics Hitachi 911 {RDI Unitized Precipitating Reagent} 
(55537)
    Roche Diagnostics Hitachi 911 {Wako L-Type LDL-C} (55544)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 {DMA One Shots} (55555)
    Roche Diagnostics Hitachi 914 {RDI Unitized LipiDirect Magnetic 
LDL} (55556)
    Roche Diagnostics Hitachi 914 {RDI Unitized Precipitating Reagent} 
(55558)
    Roche Diagnostics Hitachi 917 {Genzyme N-geneous LDL} (55571)
    Roche Diagnostics Hitachi 917 {RDI Direct LDL} (55616)
    Roche Diagnostics Hitachi 917 {Wako L-Type LDL-C} (55576)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Schiapparelli Biosystems ACE {DMA One Shots} (auto calculations) 
(58477)
    Schiapparelli Biosystems ACE {RDI Unitized LipiDirect Magnetic LDL} 
(auto calculations) (58479)
    Schiapparelli Biosystems ACE {RDI Unitized Precipitating Reagent} 
(auto calculations) (58475)
    Technicon AXON {Wako L-Type LDL-C} (61369)
    Technicon Assist {DMA One Shots} (auto calculations) (61329)
    Technicon Assist {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (61343)
    Technicon Assist {RDI Unitized Precipitating Reagent} (auto 
calculations) (61315)
    Technicon DAX {Wako L-Type LDL-C} (61370)
    Technicon DAX 24 {Sigma Diagnostics EZ LDL} (61439)
    Technicon DAX 24 {Wako L-Type LDL-C} (61371)
    Technicon DAX 48 {Sigma Diagnostics EZ LDL} (61440)
    Technicon DAX 48 {Wako L-Type LDL-C} (61372)
    Technicon DAX 72 {Sigma Diagnostics EZ LDL} (61441)
    Technicon DAX 72 {Wako L-Type LDL-C} (61373)
    Technicon DAX 96 {Sigma Diagnostics EZ LDL} (61442)
    Technicon DAX 96 {Wako L-Type LDL-C} (61374)
    Technicon RA 100 {DMA One Shots} (auto calculations) (61327)
    Technicon RA 100 {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (61341)
    Technicon RA 100 {RDI Unitized Precipitating Reagent} (auto 
calculations) (61313)
    Technicon RA 1000 {DMA One Shots} (auto calculations) (61323)
    Technicon RA 1000 {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (61337)
    Technicon RA 1000 {RDI Unitized Precipitating Reagent} (auto 
calculations) (61309)
    Technicon RA 1000 {Sigma Diagnostics EZ LDL} (61436)
    Technicon RA 1000 {Wako L-Type LDL-C} (61368)
    Technicon RA 2000 {DMA One Shots} (auto calculations) (61319)
    Technicon RA 2000 {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (61333)
    Technicon RA 2000 {RDI Unitized Precipitating Reagent} (auto 
calculations) (61305)
    Technicon RA 500 {DMA One Shots} (auto calculations) (61325)
    Technicon RA 500 {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (61339)
    Technicon RA 500 {RDI Unitized Precipitating Reagent} (auto 
calculations) (61311)
    Technicon RA 500 {Sigma Diagnostics EZ LDL} (61435)
    Technicon RA XT {DMA One Shots} (auto calculations) (61321)
    Technicon RA XT {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (61335)
    Technicon RA XT {RDI Unitized Precipitating Reagent} (auto 
calculations) (61307)
    Technicon RA XT {Sigma Diagnostics EZ LDL} (61437)
    Technicon opeRA {DMA One Shots} (auto calculations) (61317)
    Technicon opeRA {RDI Unitized LipiDirect Magnetic LDL} (auto 
calculations) (61331)
    Technicon opeRA {RDI Unitized Precipitating Reagent} (auto 
calculations) (61303)
    Technicon opeRA {Sigma Diagnostics EZ LDL} (61438)
    Wako Diagnostics 30R {RDI Direct LDL} (70234)
    Wako Diagnostics 30R {Wako L-Type LDL-C} (70229)

ANALYTE: Lactate Dehydrogenase (LDH) (3701)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    HCL Laboratory Systems 200 Biochemistry Analyzer (25266)
    Instrumentation Laboratory ILAB 600 (28538)
    Johnson & Johnson Vitros 250

[[Page 51612]]

Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    Johnson & Johnson Vitros 950 IRC Chemistry System (31073)
    Johnson & Johnson Vitros DTII Chemistry System (31075)
    Olympus AU 1000 (46230)
    Olympus AU 600 (46229)
    Ortho-Clinical Diagnostics Vitros 250 (46271)
    Ortho-Clinical Diagnostics Vitros 500 (46272)
    Ortho-Clinical Diagnostics Vitros 550 (46273)
    Ortho-Clinical Diagnostics Vitros 700 (46274)
    Ortho-Clinical Diagnostics Vitros 750 XRC (46275)
    Ortho-Clinical Diagnostics Vitros 950 IRC (46276)
    Ortho-Clinical Diagnostics Vitros DTII (46278)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)
    Synermed IR 200 (58460)

ANALYTE: Lactate Dehydrogenase Heart Fraction (LDH-1) (3702)

Test System, Assay, Examination:
    Abbott ALCYON 300/300i Analyzer (04797)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Roche Diagnostics Hitachi 704 (55367)
    Roche Diagnostics Hitachi 717 (55401)
    Roche Diagnostics Hitachi 736 (55451)
    Roche Diagnostics Hitachi 737 (55464)
    Roche Diagnostics Hitachi 747 (55480)
    Roche Diagnostics Hitachi 902 (55598)
    Roche Diagnostics Hitachi 911 (55512)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics Hitachi 914 (55549)
    Roche Diagnostics Hitachi 917 (55560)
    Roche Diagnostics Hitachi Modular Analytics (55619)

ANALYTE: Lactate Dehydrogenase Liver Fraction (LLDH) (3703)

Test System, Assay, Examination:
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)

ANALYTE: Lactic Acid (Lactate) (3704)

Test System, Assay, Examination:
    AVL OMNI Combi Analyzer (04609)
    Beckman Synchron CX 9 ALX System (07932)
    Beckman Synchron LX System (08076)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Behring aca IV (13525)
    Dade Behring aca Star (13521)
    Johnson & Johnson Vitros 250 Chemistry System (31068)
    Johnson & Johnson Vitros 500 Chemistry System (31069)
    Johnson & Johnson Vitros 550 Chemistry System (31070)
    Johnson & Johnson Vitros 700 Chemistry System (31071)
    Johnson & Johnson Vitros 750 XRC Chemistry System (31072)
    J