[Federal Register Volume 65, Number 86 (Wednesday, May 3, 2000)]
[Notices]
[Pages 25796-25814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10876]



[[Page 25795]]

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Part II





Department of Health and Human Services





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Centers for Disease Control and Prevention



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

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / 
Notices

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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.

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SUMMARY: Regulations at 42 CFR 493.15 and 493.17, implementing the 
Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 
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 1,130 test 
systems, assays, and examinations categorized by CDC as moderate or 
high complexity with categorization notification to manufacturers 
between September 4, 1999 and January 31, 2000; and 46 test systems, 
assays, and examinations CDC determined as waived with notification to 
manufacturers between September 4, 1999 and February 28, 2000. HHS 
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.

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 June 2, 2000. 
HHS 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.

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

SUPPLEMENTARY INFORMATION: CDC also maintains an electronic list of 
categorized tests which is available via the Internet (http://www.phppo.cdc.gov/dls/clia/testcat.asp).

Comments and Responses

    On September 23, 1999, a test list of approximately 5,700 test 
systems, assays, and examinations categorized by level of complexity 
was published in the Federal Register (64 FR 51590) with a 30 day 
comment period. CDC received no comment letters in regard to this 
Notice.

Correction

    Upon reevaluation, the complexity categorization for the analyte 
Heparin Dose Response (2539) was changed from Moderate to High when 
performed using the following test systems:

ITC Factor VI (28093);
ITC HEMOCHRON 400 (28094);
ITC HEMOCHRON 401 (28095);
ITC HEMOCHRON 800 (28096);
ITC HEMOCHRON 801 (28097).
    These systems require manual calculations and a manually plotted 
graph to calculate the final recommended heparin dose results.

    Dated: April 26, 2000.
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
SPECIALITY/SUBSPECIALITY: Bacteriology
ANALYTE: Clostridium difficile (1022)

TEST SYSTEM, ASSAY, EXAMINATION:

    BioStar CdTOX A OIA (08228)
ANALYTE: Gardnerella vaginalis (2212)

TEST SYSTEM, ASSAY, EXAMINATION:

    BioStar Acceava Gardnerella vaginalis PIP Activity Test Card (from 
vaginal swab) (08222)
ANALYTE: Streptococcus pneumoniae (5808)

TEST SYSTEM, ASSAY, EXAMINATION:

Binax NOW Streptococcus pneumoniae Urinary Antigen Test (08220)
SPECIALITY/SUBSPECIALITY: Endocrinology
ANALYTE: Collagen Type I Crosslink, N-telopeptides (NTx) (1125)

TEST SYSTEM, ASSAY, EXAMINATION:

    Ostex International Osteomark NTx Point of Care (POC) (46321)
ANALYTE: Cortisol (1032)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    TOSOH AIA-600 II (61464)
ANALYTE: Erythropoietin (1611)

TEST SYSTEM, ASSAY, EXAMINATION:

    Nichols Institute Advantage Chemiluminescence System (43122)
ANALYTE: Estradiol (1605)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    TOSOH AIA-600 II (61464)
ANALYTE: Follicle Stimulating Hormone (FSH) (1908)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    TOSOH AIA-600 II (61464)
ANALYTE: HCG, Beta, Serum, Quantitative (2502)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    TOSOH AIA-600 II (61464)
ANALYTE: HCG, Intact, Serum, Quantitative (2567)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (61464)
ANALYTE: HCG, Serum, Qualitative (2501)

TEST SYSTEM, ASSAY, EXAMINATION:

    Fisher HealthCare Sure-Vue Serum/Urine hCG (19041)
    Fisher HealthCare Sure-Vue Serum/Urine hCG-STAT (19040)
ANALYTE: HCG, Urine (2503)

TEST SYSTEM, ASSAY, EXAMINATION:

    Germaine Laboratories Aim Direct

[[Page 25797]]

Pregnancy (22272)
ANALYTE: Human Growth Hormone (GH) (2547)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (61464)
ANALYTE: Insulin (2812)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (61464)
ANALYTE: Luteinizing Hormone (LH) (3713)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    TOSOH AIA-600 II (61464)
ANALYTE: Parathyroid Hormone--Intact (4924)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Elecsys 1010 Analyzer (55361)
    Roche Diagnostics Elecsys 2010 Analyzer (55362)
ANALYTE: Progesterone (4914)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    TOSOH AIA-600 II (61464)
ANALYTE: Prolactin (4915)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    TOSOH AIA-600 II (61464)
ANALYTE: T Uptake (TU) (6156)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    TOSOH AIA-600 II (61464)
ANALYTE: Thyroid Stimulating Hormone (TSH) (6106)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    TOSOH AIA-600 II (61464)
ANALYTE: Thyroid Stimulating Hormone (TSH) Third Generation (6155)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    TOSOH AIA-600 II (61464)
ANALYTE: Thyroxine (T4) (6109)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    TOSOH AIA-600 II (61464)
ANALYTE: Thyroxine, Free (FT4) (6111)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    TOSOH AIA-600 II (61464)
ANALYTE: Triiodothyronine (T3) (6119)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    TOSOH AIA-600 II (61464)
ANALYTE: Triiodothyronine Uptake (T3U) (TU) (6120)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Triiodothyronine, Free (FT3) (6121)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    TOSOH AIA-600 II (61464)
SPECIALITY/SUBSPECIALITY: General Chemistry
ANALYTE: Acid Phosphatase (0407)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
ANALYTE: Alanine Aminotransferase (ALT) (SGPT) (0404)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Cholestech L.D.X. (10170)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Albumin (0414)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Alkaline Phosphatase (ALP) (0416)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Ammonia, Plasma/Serum (0427)

TEST SYSTEM, ASSAY, EXAMINATION:

    CARESIDE CareSide Analyzer (10445)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Amylase (0429)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Amylase, pancreatic isoenzymes (p-Amylase) (0500)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Apolipoprotein A1 (0462)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Beckman Synchron CX4 {Kamiya K-Assay} (08245)
    Beckman Synchron CX5 {Kamiya K-Assay} (08246)
    Beckman Synchron CX7 {Kamiya K-Assay} (08247)
    Instrumentation Laboratory ILAB 1800 {Kamiya K-Assay} (28572)
    Instrumentation Laboratory ILAB 600 {Kamiya K-Assay} (28571)
    Instrumentation Laboratory ILAB 900 {Kamiya K-Assay} (28573)
    Olympus AU 1000 {Kamiya K-Assay} (46328)
    Olympus AU 5000 {Kamiya K-Assay} (46330)
    Olympus AU 600 {Kamiya K-Assay} (46326)
    Olympus AU 800 {Kamiya K-Assay} (46327)
    Olympus Reply/AU 560 {Kamiya K-Assay} (46329)
    Roche Diagnostics Cobas FARA {Kamiya K-Assay} (55663)
    Roche Diagnostics Cobas FARA II {Kamiya K-Assay} (55664)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA

[[Page 25798]]

700 (55643)
    Roche Diagnostics Cobas Mira {Kamiya K-Assay} (55654)
    Roche Diagnostics Cobas Mira Plus {Kamiya K-Assay} (55656)
    Roche Diagnostics Cobas Mira S {Kamiya K-Assay} (55655)
    Roche Diagnostics Hitachi 704 {Kamiya K-Assay} (55657)
    Roche Diagnostics Hitachi 717 {Kamiya K-Assay} (55658)
    Roche Diagnostics Hitachi 747 {Kamiya K-Assay} (55660)
    Roche Diagnostics Hitachi 911 {Kamiya K-Assay} (55661)
    Roche Diagnostics Hitachi 914 {Kamiya K-Assay} (55659)
    Roche Diagnostics Hitachi 917 {Kamiya K-Assay} (55662)
    Technicon AXON {Kamiya K-Assay} (61460)
    Wako Diagnostics 30R {Kamiya K-Assay} (70236)
ANALYTE: Apolipoprotein B (0457)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Beckman Synchron CX4 {Kamiya K-Assay} (08245)
    Beckman Synchron CX5 {Kamiya K-Assay} (08246)
    Beckman Synchron CX7 {Kamiya K-Assay} (08247)
    Instrumentation Laboratory ILAB 1800 {Kamiya K-Assay} (28572)
    Instrumentation Laboratory ILAB 600 {Kamiya K-Assay} (28571)
    Instrumentation Laboratory ILAB 900 {Kamiya K-Assay} (28573)
    Olympus AU 1000 {Kamiya K-Assay} (46328)
    Olympus AU 5000 {Kamiya K-Assay} (46330)
    Olympus AU 600 {Kamiya K-Assay} (46326)
    Olympus AU 800 {Kamiya K-Assay} (46327)
    Olympus Reply/AU 560 {Kamiya K-Assay} (46329)
    Roche Diagnostics Cobas FARA {Kamiya K-Assay} (55663)
    Roche Diagnostics Cobas FARA II {Kamiya K-Assay} (55664)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Cobas Mira {Kamiya K-Assay} (55654)
    Roche Diagnostics Cobas Mira Plus {Kamiya K-Assay} (55656)
    Roche Diagnostics Cobas Mira S {Kamiya K-Assay} (55655)
    Roche Diagnostics Hitachi 704 {Kamiya K-Assay} (55657)
    Roche Diagnostics Hitachi 717 {Kamiya K-Assay} (55658)
    Roche Diagnostics Hitachi 747 {Kamiya K-Assay} (55660)
    Roche Diagnostics Hitachi 911 {Kamiya K-Assay} (55661)
    Roche Diagnostics Hitachi 914 {Kamiya K-Assay} (55659)
    Roche Diagnostics Hitachi 917 {Kamiya K-Assay} (55662)
    Technicon AXON {Kamiya K-Assay} (61460)
    Wako Diagnostics 30R {Kamiya K-Assay} (70236)
ANALYTE: Aspartate Aminotransferase (AST) (SGOT) (0405)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Bilirubin, Direct (0704)

TEST SYSTEM, ASSAY, EXAMINATION:

    CARESIDE CareSide Analyzer (10445)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Bilirubin, Neonatal (0705)

TEST SYSTEM, ASSAY, EXAMINATION:

    Arrows UB Analyzer UA-2 (04888)
ANALYTE: Bilirubin, Total (0706)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Bilirubin, Unbound (0748)

TEST SYSTEM, ASSAY, EXAMINATION:

    Arrows UB Analyzer UA-2 (04888)
ANALYTE: Blood Gases (0708)

TEST SYSTEM, ASSAY, EXAMINATION:

    Instrumentation Laboratory GEM Premier 3000 (28583)
    Nova Stat Profile M7 (43129)
    Radiometer ABL NPT7 Series Analyzers (55645)
ANALYTE: C-Peptide (1040)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (61464)
ANALYTE: Calcium, Ionized (1004)

TEST SYSTEM, ASSAY, EXAMINATION:

    Instrumentation Laboratory GEM Premier 3000 (28583)
    Nova Stat Profile M7 (43129)
ANALYTE: Calcium, Total (1005)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Cancer Antigen 125 (CA 125) (1049)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (61464)
ANALYTE: Carbon Dioxide, Total (CO2) (1003)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abaxis Piccolo Portable Blood Analyzer (04608)
    CARESIDE CareSide Analyzer (10445)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Carcinoembryonic Antigen (CEA) (1013)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (61464)
ANALYTE: Ceruloplasmin (1015)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Chloride (1018)

TEST SYSTEM, ASSAY, EXAMINATION:

    Nova Stat Profile M7 (43129)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Cholesterol (1020)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Cholinesterase (1021)

TEST SYSTEM, ASSAY, EXAMINATION:

    EQM Research Test-mate ChE Cholinesterase Test System {AChE/PChE 
Assay} (16194)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Creatine Kinase (CK) (1034)

[[Page 25799]]

TEST SYSTEM, ASSAY, EXAMINATION:

    Abaxis Piccolo Portable Blood Analyzer (04608)
    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Creatine Kinase MB Fraction (CKMB) (1002)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    TOSOH AIA-600 II (61464)
ANALYTE: Creatinine (1035)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Nova Stat Profile M7 (43129)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Deoxyhemoglobin (Reduced Hemoglobin) (1318)

TEST SYSTEM, ASSAY, EXAMINATION:

    Radiometer ABL NPT7 Series Analyzers (55645)
ANALYTE: Ferritin (1902)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Nichols Institute Advantage Chemiluminescence System (43122)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    TOSOH AIA-600 II (61464)
ANALYTE: Folate (Folic acid) (1907)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (auto pre-treatment) (61465)
    TOSOH AIA-600 II (manual pre-treatment) (61466)
ANALYTE: Fructosamine (1914)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Gamma Glutamyl Transferase (GGT) (2201)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Glucose (2203)

TEST SYSTEM, ASSAY, EXAMINATION:

    AVL OPTI Critical Care Analyzer (04778)
    Bayer ADVIA IMS (08254)
    Nova Stat Profile M7 (43129)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Glycosylated Hemoglobin (Hgb A1C) (2204)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: HDL Cholesterol (2550)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Spectrum {DCL Dextran Sulfate/Magnesium Uni-Paks} (04642)
    Abbott VP {DCL Dextran Sulfate/Magnesium Uni-Paks} (04643)
    Beckman Synchron CX4 {Kamiya K-Assay} (08245)
    Beckman Synchron CX5 {Kamiya K-Assay} (08246)
    Beckman Synchron CX7 {Kamiya K-Assay} (08247)
    Chiron Diagnostics 550 Express {DCL Dextran Sulfate/Magnesium Uni-
Paks} (10377)
    Chiron Diagnostics 550 Express {Kamiya K-Assay} (10493)
    Ciba Corning 550 Express {DCL Dextran Sulfate/Magnesium Uni-Paks} 
(10327)
    Dade Dimension {Randox Direct HDL} (13599)
    Dade Dimension AR {Randox Direct HDL} (13601)
    Dade Dimension ES {Randox Direct HDL} (13603)
    Dade Dimension RxL {Randox Direct HDL} (13605)
    Dade Dimension XL {Randox Direct HDL} (13607)
    Electronucleonics Gemini {DCL Dextran Sulfate/Magnesium Uni-Paks} 
(16119)
    Electronucleonics Gemstar {DCL Dextran Sulfate/Magnesium Uni-Paks} 
(16120)
    Instrumentation Laboratory IL Monarch {DCL Dextran Sulfate/
Magnesium Uni-Paks} (28435)
    Instrumentation Laboratory ILAB 1800 {Kamiya K-Assay} (28572)
    Instrumentation Laboratory ILAB 900 {Kamiya K-Assay} (28573)
    Olympus AU 5000 {DCL Dextran Sulfate/Magnesium Uni-Paks} (46213)
    Olympus AU 800 {Kamiya K-Assay} (46327)
    Roche Diagnostics Cobas Bio {DCL Dextran Sulfate/Magnesium Uni-
Paks} (55189)
    Roche Diagnostics Cobas FARA {DCL Dextran Sulfate/Magnesium Uni-
Paks} (55191)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Cobas INTEGRA 700 {COBAS INTEGRA HDL-Cholesterol 
Direct} (55644)
    Roche Diagnostics Cobas Mira {DCL Dextran Sulfate/Magnesium Uni-
Paks} (55193)
    Roche Diagnostics Cobas Mira {Kamiya K-Assay} (55654)
    Roche Diagnostics Cobas Mira S {DCL Dextran Sulfate/Magnesium Uni-
Paks} (55195)
    Roche Diagnostics Cobas Mira S {Kamiya K-Assay} (55655)
    Roche Diagnostics Hitachi 704 {DCL Dextran Sulfate/Magnesium Uni-
Paks} (55378)
    Roche Diagnostics Hitachi 704 {Kamiya K-Assay} (55657)
    Roche Diagnostics Hitachi 717 {DCL Dextran Sulfate/Magnesium Uni-
Paks} (55424)
    Roche Diagnostics Hitachi 717 {Kamiya K-Assay} (55658)
    Roche Diagnostics Hitachi 737 {DCL Dextran Sulfate/Magnesium Uni-
Paks} (55466)
    Roche Diagnostics Hitachi 737 {Kamiya K-Assay} (55666)
    Roche Diagnostics Hitachi 747 {Kamiya K-Assay} (55660)
    Roche Diagnostics Hitachi 911 {Kamiya K-Assay} (55661)
    Roche Diagnostics Hitachi 912 {Randox Direct HDL} (55684)
    Roche Diagnostics Hitachi 917 {Kamiya K-Assay} (55662)
    StatChem StatTest Sysem (58269)
    Technicon RA 100 {Kamiya K-Assay} (61456)
    Technicon RA 1000 {DCL Dextran Sulfate/Magnesium Uni-Paks} (61223)
    Technicon RA 1000 {Kamiya K-Assay} (61457)
    Technicon RA 2000 {Kamiya K-Assay} (61458)
    Technicon RA 500 {DCL Dextran Sulfate/Magnesium Uni-Paks} (61221)

[[Page 25800]]

    Technicon RA 500 {Kamiya K-Assay} (61459)
    Technicon RA XT {DCL Dextran Sulfate/Magnesium Uni-Paks} (61225)
    Technicon RA XT {Kamiya K-Assay} (61455)
ANALYTE: Haptoglobin (2511)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Beckman Synchron CX4 {Kamiya K-Assay} (08245)
    Beckman Synchron CX5 {Kamiya K-Assay} (08246)
    Beckman Synchron CX7 {Kamiya K-Assay} (08247)
    Instrumentation Laboratory ILAB 1800 {Kamiya K-Assay} (28572)
    Instrumentation Laboratory ILAB 600 {Kamiya K-Assay} (28571)
    Instrumentation Laboratory ILAB 900 {Kamiya K-Assay} (28573)
    Olympus AU 1000 {Kamiya K-Assay} (46328)
    Olympus AU 600 {Kamiya K-Assay} (46326)
    Olympus AU 800 {Kamiya K-Assay} (46327)
    Olympus Reply/AU 560 {Kamiya K-Assay} (46329)
    Roche Diagnostics Cobas FARA {Kamiya K-Assay} (55663)
    Roche Diagnostics Cobas FARA II {Kamiya K-Assay} (55664)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Cobas Mira {Kamiya K-Assay} (55654)
    Roche Diagnostics Cobas Mira Plus {Kamiya K-Assay} (55656)
    Roche Diagnostics Cobas Mira S {Kamiya K-Assay} (55655)
    Roche Diagnostics Hitachi 704 {Kamiya K-Assay} (55657)
    Roche Diagnostics Hitachi 717 {Kamiya K-Assay} (55658)
    Roche Diagnostics Hitachi 747 {Kamiya K-Assay} (55660)
    Roche Diagnostics Hitachi 911 {Kamiya K-Assay} (55661)
    Roche Diagnostics Hitachi 914 {Kamiya K-Assay} (55659)
    Roche Diagnostics Hitachi 917 {Kamiya K-Assay} (55662)
    Wako Diagnostics 30R {Kamiya K-Assay} (70236)
ANALYTE: Hemoglobin A2 (2535)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad VARIANT II Beta-Thalassemia Short Program (08229)
ANALYTE: Hemoglobin F (2516)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad VARIANT II Beta-Thalassemia Short Program (08229)
ANALYTE: Hemoglobin Fractions (2544)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad VARIANT II Beta-Thalassemia Short Program (08229)
ANALYTE: Hemoglobin S (2536)

TEST SYSTEM, ASSAY, EXAMINATION:

    True Medix Sickle-Scan HbS (61138)
ANALYTE: Iron (2814)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Iron Binding Capacity, Unsat. (UIBC) no pretreat. (2823)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: LDL Cholesterol (3748)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Synchron CX 4 {Randox Direct LDL} (08256)
    Beckman Synchron CX 5 {Randox Direct LDL} (08257)
    Beckman Synchron CX 7 {Randox Direct LDL} (08258)
    Dade Dimension {Randox Direct LDL} (13598)
    Dade Dimension AR {Randox Direct LDL} (13600)
    Dade Dimension ES {Randox Direct LDL} (13602)
    Dade Dimension RxL {Randox Direct LDL} (13604)
    Dade Dimension XL {Randox Direct LDL} (13606)
    Olympus AU 600 {Genzyme N-geneous LDL-ST} (46324)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Cobas Mira {Randox Direct LDL} (55674)
    Roche Diagnostics Cobas Mira Plus {Randox Direct LDL} (55675)
    Roche Diagnostics Cobas Mira S {Randox Direct LDL} (55676)
    Roche Diagnostics Hitachi 704 {Randox Direct LDL} (55677)
    Roche Diagnostics Hitachi 717 {Randox Direct LDL} (55678)
    Roche Diagnostics Hitachi 737 {Randox Direct LDL} (55679)
    Roche Diagnostics Hitachi 747 {Randox Direct LDL} (55680)
    Roche Diagnostics Hitachi 911 {Randox Direct LDL} (55681)
    Roche Diagnostics Hitachi 912 {Randox Direct LDL} (55682)
    Roche Diagnostics Hitachi 917 {Randox Direct LDL} (55683)
ANALYTE: Lactate Dehydrogenase (LDH) (3701)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Lactate Dehydrogenase Heart Fraction (LDH-1) (3702)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Lactic Acid (Lactate) (3704)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Nova Stat Profile M7 (43129)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Lipase (3711)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Lipoprotein(a) (Lp(a)) (3755)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Hitachi 911 {DiaSorin SPQ Ab Rgt Set for Lp(a)} 
(55685)
ANALYTE: Magnesium (4002)

TEST SYSTEM, ASSAY, EXAMINATION:

    CARESIDE CareSide Analyzer (10445)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Methemoglobin (4032)

TEST SYSTEM, ASSAY, EXAMINATION:

    Radiometer ABL NPT7 Series Analyzers (55645)
ANALYTE: Microalbumin (4019)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)

[[Page 25801]]

ANALYTE: Myoglobin (4023)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Cobas Mira {Spectral Diagnostics Multiquant} 
(55653)
    TOSOH AIA-600 II (61464)
ANALYTE: Oxyhemoglobin/Oxygen Saturation (4604)

TEST SYSTEM, ASSAY, EXAMINATION:

    Nova Stat Profile M7 (43129)
    Radiometer ABL NPT7 Series Analyzers (55645)
ANALYTE: PCO2 (4983)

TEST SYSTEM, ASSAY, EXAMINATION:

    Instrumentation Laboratory GEM Premier 3000 (28583)
    Nova Stat Profile M7 (43129)
    Radiometer ABL NPT7 Series Analyzers (55645)
ANALYTE: PO2 (4984)

TEST SYSTEM, ASSAY, EXAMINATION:

    Instrumentation Laboratory GEM Premier 3000 (28583)
    Nova Stat Profile M7 (43129)
    Radiometer ABL NPT7 Series Analyzers (55645)
ANALYTE: Phosphorus (4906)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Potassium (4910)

TEST SYSTEM, ASSAY, EXAMINATION:

    Instrumentation Laboratory GEM Premier 3000 (28583)
    Nova Stat Profile M7 (43129)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Prealbumin (4911)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Prostatic Acid Phosphatase (PAP) (4918)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    TOSOH AIA-600 II (61464)
ANALYTE: Prostatic Specific Antigen (PSA) (4919)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (61464)
ANALYTE: Prostatic Specific Antigen (PSA), Free (4990)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman ACCESS Immunoassay System (07914)
ANALYTE: Protein, Glycated (4963)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Synchron CX4 {Genzyme GlyPro} (08234)
    Beckman Synchron CX4 CE {Genzyme GlyPro} (08235)
    Beckman Synchron CX4 Delta {Genzyme GlyPro} (08236)
    Beckman Synchron CX5 {Genzyme GlyPro} (08237)
    Beckman Synchron CX5 CE {Genzyme GlyPro} (08238)
    Beckman Synchron CX5 Delta {Genzyme GlyPro} (08239)
    Beckman Synchron CX7 {Genzyme GlyPro} (08240)
    Beckman Synchron CX7 Delta {Genzyme GlyPro} (08241)
    Chiron Diagnostics 550 Express {Genzyme GlyPro} (10488)
    Olympus AU 600 {Genzyme GlyPro} (46325)
    Roche Diagnostics Hitachi 717 {Genzyme GlyPro} (55647)
    Roche Diagnostics Hitachi 911 {Genzyme GlyPro} (55646)
ANALYTE: Protein, Total (4921)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Protein, Total (urine) (4972)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
ANALYTE: Sodium (5805)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abaxis Piccolo Portable Blood Analyzer (04608)
    Instrumentation Laboratory GEM Premier 3000 (28583)
    Nova Stat Profile M7 (43129)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Transferrin (6114)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Abbott Aeroset {Wako Transferrin} (04880)
    Bayer ADVIA IMS (08254)
    Beckman Synchron CX4 {Kamiya K-Assay} (08245)
    Beckman Synchron CX5 {Kamiya K-Assay} (08246)
    Beckman Synchron CX7 {Kamiya K-Assay} (08247)
    Instrumentation Laboratory ILAB 1800 {Kamiya K-Assay} (28572)
    Instrumentation Laboratory ILAB 600 {Kamiya K-Assay} (28571)
    Instrumentation Laboratory ILAB 900 {Kamiya K-Assay} (28573)
    Olympus AU 1000 {Kamiya K-Assay} (46328)
    Olympus AU 600 {Kamiya K-Assay} (46326)
    Olympus AU 800 {Kamiya K-Assay} (46327)
    Olympus Reply/AU 560 {Kamiya K-Assay} (46329)
    Roche Diagnostics Cobas FARA {Kamiya K-Assay} (55663)
    Roche Diagnostics Cobas FARA II {Kamiya K-Assay} (55664)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Cobas Mira {Kamiya K-Assay} (55654)
    Roche Diagnostics Cobas Mira {Wako Transferrin} (55648)
    Roche Diagnostics Cobas Mira Plus {Kamiya K-Assay} (55656)
    Roche Diagnostics Cobas Mira S {Kamiya K-Assay} (55655)
    Roche Diagnostics Hitachi 704 {Kamiya K-Assay} (55657)
    Roche Diagnostics Hitachi 704 {Wako Transferrin} (55649)
    Roche Diagnostics Hitachi 717 {Kamiya K-Assay} (55658)
    Roche Diagnostics Hitachi 717 {Wako Transferrin} (55650)
    Roche Diagnostics Hitachi 736 {Kamiya K-Assay} (55665)
    Roche Diagnostics Hitachi 747 {Kamiya K-Assay} (55660)
    Roche Diagnostics Hitachi 911 {Kamiya K-Assay} (55661)
    Roche Diagnostics Hitachi 911 {Wako Transferrin} (55651)
    Roche Diagnostics Hitachi 914 {Kamiya K-Assay} (55659)

[[Page 25802]]

    Roche Diagnostics Hitachi 917 {Kamiya K-Assay} (55662)
    Roche Diagnostics Hitachi 917 {Wako Transferrin} (55652)
    Wako Diagnostics 30R (70002)
    Wako Diagnostics 30R {Kamiya K-Assay} (70236)
ANALYTE: Transferrin Receptor (TfR) (6158)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring Nephelometer {N Latex sTfR} (08225)
    Behring Nephelometer 100 {N Latex sTfR} (08226)
    Behring Nephelometer II {N Latex sTfR} (08227)
ANALYTE: Triglyceride (6118)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Troponin-I (Cardiac) (6153)

TEST SYSTEM, ASSAY, EXAMINATION:

    Ortho-Clinical Diagnostics Vitros ECi (46279)
    TOSOH AIA-600 II (61464)
ANALYTE: Urea (BUN) (6403)

TEST SYSTEM, ASSAY, EXAMINATION:

    AVL OPTI Critical Care Analyzer (04778)
    Bayer ADVIA IMS (08254)
    Nova Stat Profile M7 (43129)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Uric Acid (6404)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Vitamin B12 (6707)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (auto pre-treatment) (61465)
    TOSOH AIA-600 II (manual pre-treatment) (61466)
ANALYTE: pH (4982)

TEST SYSTEM, ASSAY, EXAMINATION:

    Instrumentation Laboratory GEM Premier 3000 (28583)
    Nova Stat Profile M7 (43129)
    Radiometer ABL NPT7 Series Analyzers (55645)
SPECIALITY/SUBSPECIALITY: General Immunology
ANALYTE: Allergen specific IgE (0417)

TEST SYSTEM, ASSAY, EXAMINATION:

    Hycor HY-TEC Automated EIA System {Specific IgE EIA} (25314)
ANALYTE: Alpha-1-Acid Glycoprotein (orosomucoid) (0420)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Synchron CX4 {Kamiya K-Assay} (08245)
    Beckman Synchron CX5 {Kamiya K-Assay} (08246)
    Beckman Synchron CX7 {Kamiya K-Assay} (08247)
    Instrumentation Laboratory ILAB 1800 {Kamiya K-Assay} (28572)
    Instrumentation Laboratory ILAB 600 {Kamiya K-Assay} (28571)
    Instrumentation Laboratory ILAB 900 {Kamiya K-Assay} (28573)
    Olympus AU 1000 {Kamiya K-Assay} (46328)
    Olympus AU 600 {Kamiya K-Assay} (46326)
    Olympus AU 800 {Kamiya K-Assay} (46327)
    Roche Diagnostics Cobas FARA {Kamiya K-Assay} (55663)
    Roche Diagnostics Cobas FARA II {Kamiya K-Assay} (55664)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Cobas Mira {Kamiya K-Assay} (55654)
    Roche Diagnostics Cobas Mira Plus {Kamiya K-Assay} (55656)
    Roche Diagnostics Cobas Mira S {Kamiya K-Assay} (55655)
    Roche Diagnostics Hitachi 704 {Kamiya K-Assay} (55657)
    Roche Diagnostics Hitachi 717 {Kamiya K-Assay} (55658)
    Roche Diagnostics Hitachi 747 {Kamiya K-Assay} (55660)
    Roche Diagnostics Hitachi 911 {Kamiya K-Assay} (55661)
    Roche Diagnostics Hitachi 914 {Kamiya K-Assay} (55659)
    Roche Diagnostics Hitachi 917 {Kamiya K-Assay} (55662)
    Wako Diagnostics 30R {Kamiya K-Assay} (70236)
    ANALYTE: Alpha-1-Antitrypsin (0421)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman Synchron CX4 {Kamiya K-Assay} (08245)
    Beckman Synchron CX5 {Kamiya K-Assay} (08246)
    Beckman Synchron CX7 {Kamiya K-Assay} (08247)
    Instrumentation Laboratory ILAB 1800 {Kamiya K-Assay} (28572)
    Instrumentation Laboratory ILAB 600 {Kamiya K-Assay} (28571)
    Instrumentation Laboratory ILAB 900 {Kamiya K-Assay} (28573)
    Olympus AU 1000 {Kamiya K-Assay} (46328)
    Olympus AU 600 {Kamiya K-Assay} (46326)
    Olympus AU 800 {Kamiya K-Assay} (46327)
    Roche Diagnostics Cobas FARA {Kamiya K-Assay} (55663)
    Roche Diagnostics Cobas FARA II {Kamiya K-Assay} (55664)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Cobas Mira {Kamiya K-Assay} (55654)
    Roche Diagnostics Cobas Mira Plus {Kamiya K-Assay} (55656)
    Roche Diagnostics Cobas Mira S {Kamiya K-Assay} (55655)
    Roche Diagnostics Hitachi 704 {Kamiya K-Assay} (55657)
    Roche Diagnostics Hitachi 717 {Kamiya K-Assay} (55658)
    Roche Diagnostics Hitachi 747 {Kamiya K-Assay} (55660)
    Roche Diagnostics Hitachi 911 {Kamiya K-Assay} (55661)
    Roche Diagnostics Hitachi 914 {Kamiya K-Assay} (55659)
    Roche Diagnostics Hitachi 917 {Kamiya K-Assay} (55662)
    Wako Diagnostics 30R {Kamiya K-Assay} (70236)
ANALYTE: Alpha-Fetoprotein--Tumor Marker (0424)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (61464)
ANALYTE: Anti-Cardiolipin Antibodies (0434)

TEST SYSTEM, ASSAY, EXAMINATION:

    Hycor HY-TEC Automated EIA System {Anti-Cardiolipin IgG} (25310)
    Hycor HY-TEC Automated EIA System {Anti-Cardiolipin IgM} (25311)
ANALYTE: Anti-Gliadin Antibodies (0528)

TEST SYSTEM, ASSAY, EXAMINATION:

    Hycor HY-TEC Automated EIA System {Anti-Gliadin IgA} (25305)
    Hycor HY-TEC Automated EIA

[[Page 25803]]

System {Anti-Gliadin IgG} (25303)
    Sigma Diagnostics APTUS {Gliadin IgG} (58594)
ANALYTE: Anti-Glomerular Basement Membrane (GBM) Antibodies (0524)

TEST SYSTEM, ASSAY, EXAMINATION:

    Hycor HY-TEC Automated EIA System {Anti-GBM ELISA} (25301)
ANALYTE: Anti-Myeloperoxidase (MPO) Antibodies (0505)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diamedix MAGO Plus {Diamedix Immunosimplicity (Is)-MPO (P-ANCA) 
IgG} (13589)
ANALYTE: Anti-Parietal Cell Antibodies (0442)

TEST SYSTEM, ASSAY, EXAMINATION:

    Hycor HY-TEC Automated EIA System {Anti-GPC ELISA} (25299)
ANALYTE: Anti-Proteinase-3 (PR-3) Antibodies (0525)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diamedix MAGO Plus {Diamedix Immunosimplicity (Is)-anti-PR-3 (C-
ANCA) IgG} (13586)
ANALYTE: Anti-Streptolysin O (ASO) (0452)

TEST SYSTEM, ASSAY, EXAMINATION:

    CENOGENICS ACCULYSIN-O (10485)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Anti-Thyroglobulin Antibodies (0453)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diamedix MAGO Plus {Diamedix Immunosimplicity (Is)-anti-TG IgG} 
(13590)
    Nichols Institute Advantage Chemiluminescence System (43122)
    TOSOH AIA-600 II (61464)
ANALYTE: Anti-Thyroid Peroxidase (TPO) Antibodies (0527)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (61464)
ANALYTE: Beta-2 microglobulin (0703)

TEST SYSTEM, ASSAY, EXAMINATION:

    TOSOH AIA-600 II (61464)
ANALYTE: C-Reactive Protein (CRP) (1001)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Olympus AU 800 (46110)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Cold Agglutinins (1072)

TEST SYSTEM, ASSAY, EXAMINATION:

    All Manual Macroscopic agglutination screen/titer procedures 
(04890)
ANALYTE: Complement C3 (1029)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Bayer ADVIA IMS (08254)
    Beckman Synchron CX4 {Kamiya K-Assay} (08245)
    Beckman Synchron CX5 {Kamiya K-Assay} (08246)
    Beckman Synchron CX7 {Kamiya K-Assay} (08247)
    Instrumentation Laboratory ILAB 1800 {Kamiya K-Assay} (28572)
    Instrumentation Laboratory ILAB 600 {Kamiya K-Assay} (28571)
    Instrumentation Laboratory ILAB 900 {Kamiya K-Assay} (28573)
    Olympus AU 1000 {Kamiya K-Assay} (46328)
    Olympus AU 600 {Kamiya K-Assay} (46326)
    Olympus AU 800 {Kamiya K-Assay} (46327)
    Olympus Reply/AU 560 {Kamiya K-Assay} (46329)
    Roche Diagnostics Cobas FARA {Kamiya K-Assay} (55663)
    Roche Diagnostics Cobas FARA II {Kamiya K-Assay} (55664)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Cobas Mira {Kamiya K-Assay} (55654)
    Roche Diagnostics Cobas Mira Plus {Kamiya K-Assay} (55656)
    Roche Diagnostics Cobas Mira S {Kamiya K-Assay} (55655)
    Roche Diagnostics Hitachi 704 {Kamiya K-Assay} (55657)
    Roche Diagnostics Hitachi 717 {Kamiya K-Assay} (55658)
    Roche Diagnostics Hitachi 747 {Kamiya K-Assay} (55660)
    Roche Diagnostics Hitachi 911 {Kamiya K-Assay} (55661)
    Roche Diagnostics Hitachi 914 {Kamiya K-Assay} (55659)
    Roche Diagnostics Hitachi 917 {Kamiya K-Assay} (55662)
    Technicon AXON {Kamiya K-Assay} (61460)
    The Binding Site MININEPH {MININEPH C3} (61364)
    Wako Diagnostics 30R {Kamiya K-Assay} (70236)
ANALYTE: Complement C4 (1030)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Bayer ADVIA IMS (08254)
    Beckman Synchron CX4 {Kamiya K-Assay} (08245)
    Beckman Synchron CX5 {Kamiya K-Assay} (08246)
    Beckman Synchron CX7 {Kamiya K-Assay} (08247)
    Instrumentation Laboratory ILAB 1800 {Kamiya K-Assay} (28572)
    Instrumentation Laboratory ILAB 600 {Kamiya K-Assay} (28571)
    Instrumentation Laboratory ILAB 900 {Kamiya K-Assay} (28573)
    Olympus AU 1000 {Kamiya K-Assay} (46328)
    Olympus AU 600 {Kamiya K-Assay} (46326)
    Olympus AU 800 {Kamiya K-Assay} (46327)
    Olympus Reply/AU 560 {Kamiya K-Assay} (46329)
    Roche Diagnostics Cobas FARA {Kamiya K-Assay} (55663)
    Roche Diagnostics Cobas FARA II {Kamiya K-Assay} (55664)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Cobas Mira {Kamiya K-Assay} (55654)
    Roche Diagnostics Cobas Mira Plus {Kamiya K-Assay} (55656)
    Roche Diagnostics Cobas Mira S {Kamiya K-Assay} (55655)
    Roche Diagnostics Hitachi 704 {Kamiya K-Assay} (55657)
    Roche Diagnostics Hitachi 717 {Kamiya K-Assay} (55658)
    Roche Diagnostics Hitachi 736 {Kamiya K-Assay} (55665)
    Roche Diagnostics Hitachi 747 {Kamiya K-Assay} (55660)
    Roche Diagnostics Hitachi 911 {Kamiya K-Assay} (55661)
    Roche Diagnostics Hitachi 914 {Kamiya K-Assay} (55659)
    Roche Diagnostics Hitachi 917 {Kamiya K-Assay} (55662)
    Technicon AXON {Kamiya K-Assay} (61460)
    The Binding Site MININEPH {MININEPH C4} (61365)
    Wako Diagnostics 30R {Kamiya K-Assay} (70236)
ANALYTE: Cytomegalovirus Antibodies (1039)

TEST SYSTEM ASSAY, EXAMINATION:

    Behring OPUS (07793)

[[Page 25804]]

    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Olympus PK7200 {Olympus PK CMV System} (blood donor screening only) 
(46335)
ANALYTE: Epstein-Barr virus Antibodies (1603)

TEST SYSTEM ASSAY, EXAMINATION:

    Diamedix MAGO Plus {Diamedix Immunosimplicity (Is)-EBNA-1 IgM} 
(13575)
    Diamedix MAGO Plus {Diamedix Immunosimplicity (Is)-EBV-EA-D IgG} 
(13563)
    Diamedix MAGO Plus {Diamedix Immunosimplicity (Is)-EBV-EA-D IgM} 
(13577)
    Diamedix MAGO Plus {Diamedix Immunosimplicity (Is)-EBV-VCA IgM} 
(13579)
ANALYTE: Febrile Agglutinins (1901)

TEST SYSTEM ASSAY, EXAMINATION:

    Germaine Laboratories Febrile Antigens (slide test) (22273)
    Germaine Laboratories Febrile Antigens (tube test) (22274)
ANALYTE: Helicobacter pylori Antibodies (2513)

TEST SYSTEM ASSAY, EXAMINATION:

    Diamedix MAGO Plus {Diamedix Immunosimplicity (Is)-H. pylori IgG} 
(13582)
    LifeSign Status H. pylori (serum/plasma) (37153)
     
ANALYTE: Herpes simplex I and/or II Antibodies (2530)

TEST SYSTEM, ASSAY, EXAMINATION:

    Sigma Diagnostics APTUS {Herpes-1 IgG} (58556)
    Sigma Diagnostics APTUS {Herpes-2 IgG} (58557)
ANALYTE: Immunoglobulins IgA (2803)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Bayer ADVIA IMS (08254)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    The Binding Site MININEPH {MININEPH IgA} (61362)
ANALYTE: Immunoglobulins IgE (2805)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring Nephelometer (07273)
    Behring Nephelometer II (07563)
    Hycor HY-TEC Automated EIA System {Total IgE EIA} (25313)
    TOSOH AIA-600 II (61464)
ANALYTE: Immunoglobulins IgG (2806)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Bayer ADVIA IMS (08254)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    The Binding Site MININEPH {MININEPH IgG} (61471)
ANALYTE: Immunoglobulins IgG subclasses (2807)

TEST SYSTEM, ASSAY, EXAMINATION:

    The Binding Site MININEPH {MININEPH IgG1} (61467)
    The Binding Site MININEPH {MININEPH IgG2} (61468)
    The Binding Site MININEPH {MININEPH IgG3} (61470)
    The Binding Site MININEPH {MININEPH IgG4} (61469)
ANALYTE: Immunoglobulins IgM (2808)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Bayer ADVIA IMS (08254)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    The Binding Site MININEPH {MININEPH IgM} (61363)
ANALYTE: Infectious Mononucleosis Antibodies (Mono) (2809)

TEST SYSTEM, ASSAY, EXAMINATION:

    Meridian Diagnostics ImmunoCard STAT! Mono (serum/plasma) (40334)
    Oxoid DrySpot IM Test (46323)
ANALYTE: Lyme Disease Antibodies (Borrelia burgdorferi Abs) (3714)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diamedix MAGO Plus {Diamedix Immunosimplicity (Is)-anti-Borrelia 
burgdorferi IgG/IgM} (13573)
    Diamedix MAGO Plus {Diamedix Immunosimplicity (Is)-anti-Borrelia 
burgdorferi IgM} (13571)
ANALYTE: Mumps Antibodies (4007)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diamedix MAGO Plus {Diamedix Immunosimplicity (Is)-Mumps IgG} 
(13581)
ANALYTE: Mycoplasma pneumoniae Antibodies (4016)

TEST SYSTEM, ASSAY, EXAMINATION:

    Sigma Diagnostics APTUS {Mycoplasma IgG} (58570)
ANALYTE: Rheumatoid Factor (RF) (5508)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott Aeroset (04798)
    Hycor HY-TEC Automated EIA System {IgG Rheumatoid Factor} (25309)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Rubella Antibodies (5510)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Sigma Diagnostics APTUS {Rubella IgG} (58563)
ANALYTE: Stem Cells, CD34 (5845)

TEST SYSTEM, ASSAY, EXAMINATION:

    Biometric Imaging IMAGN 2000 {STELLer CD34 Assay} (08188)
ANALYTE: Toxoplasma gondii Antibodies (6113)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Eiken Toxotest-MT Eiken (16070)
ANALYTE: Treponema pallidum Antibodies (includes Reagin) (6115)

TEST SYSTEM, ASSAY, EXAMINATION:

    DiaSorin Copalis One ImmunoAssay System {Treponemal Antigen Total 
Ab} (13567)
    Olympus PK7200 {Olympus PK TP System} (blood donor screening only) 
(46334)
SPECIALITY/SUBSPECIALITY: Hematology
ANALYTE: Activated Clotting Time (ACT) (0461)

TEST SYSTEM, ASSAY, EXAMINATION:

    ITC HEMOCHRON Response (28578)
ANALYTE: Activated Partial Thromboplastin Time (APTT) (0409)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)

[[Page 25805]]

    Dade Behring BFT II (13594)
    Dade Behring Coagulation System (BCS) (13608)
    ITC HEMOCHRON Response (28578)
    Pacific Hemostasis ThromboScreen 400C (49231)
    Sysmex CA-1000 (58604)
    Sysmex CA-5000 (58605)
    Sysmex CA-6000 (58606)
ANALYTE: Activated Protein C (APC) Resistance (0526)

TEST SYSTEM, ASSAY, EXAMINATION:

    Pacific Hemostasis ThromboScreen 400C (49231)
ANALYTE: Antithrombin III (ATIII) (0456)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Behring Coagulation System (BCS) (13608)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: D-dimer (1320)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer {STA-Liatest D-di} (04876)
ANALYTE: Erythrocyte Sedimentation Rate (non-waived proced) (1613)

TEST SYSTEM, ASSAY, EXAMINATION:

    AI AnalysInstrument AB ESR-100 (04879)
    Polymedco SEDIPLAST ESR {Sedimat Reader} (49220)
ANALYTE: Fibrinogen (1905)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)
    Beckman Synchron CX4 {Kamiya K-Assay} (08245)
    Beckman Synchron CX5 {Kamiya K-Assay} (08246)
    Beckman Synchron CX7 {Kamiya K-Assay} (08247)
    Dade Behring BFT II (13594)
    Dade Behring Coagulation System (BCS) (13608)
    ITC HEMOCHRON Response (28578)
    Instrumentation Laboratory ILAB 1800 {Kamiya K-Assay} (28572)
    Instrumentation Laboratory ILAB 600 {Kamiya K-Assay} (28571)
    Instrumentation Laboratory ILAB 900 {Kamiya K-Assay} (28573)
    Olympus AU 1000 {Kamiya K-Assay} (46328)
    Olympus AU 600 {Kamiya K-Assay} (46326)
    Olympus AU 800 {Kamiya K-Assay} (46327)
    Olympus Reply/AU 560 {Kamiya K-Assay} (46329)
    Pacific Hemostasis ThromboScreen 400C (49231)
    Roche Diagnostics Cobas FARA {Kamiya K-Assay} (55663)
    Roche Diagnostics Cobas FARA II {Kamiya K-Assay} (55664)
    Roche Diagnostics Cobas Mira {Kamiya K-Assay} (55654)
    Roche Diagnostics Cobas Mira Plus {Kamiya K-Assay} (55656)
    Roche Diagnostics Cobas Mira S {Kamiya K-Assay} (55655)
    Roche Diagnostics Hitachi 704 {Kamiya K-Assay} (55657)
    Roche Diagnostics Hitachi 717 {Kamiya K-Assay} (55658)
    Roche Diagnostics Hitachi 747 {Kamiya K-Assay} (55660)
    Roche Diagnostics Hitachi 911 {Kamiya K-Assay} (55661)
    Roche Diagnostics Hitachi 914 {Kamiya K-Assay} (55659)
    Roche Diagnostics Hitachi 917 {Kamiya K-Assay} (55662)
    Sysmex CA-1000 (58604)
    Sysmex CA-5000 (58605)
    Sysmex CA-6000 (58606)
    Wako Diagnostics 30R {Kamiya K-Assay} (70236)
ANALYTE: Hematocrit (2514)

TEST SYSTEM, ASSAY, EXAMINATION:

    ABX Diagnostics PENTRA 60 (04877)
    Bayer ADVIA 60 (08224)
    Becton Dickinson QBC STAR (08233)
    Instrumentation Laboratory GEM Premier 3000 (28583)
    Nova Stat Profile M7 (43129)
    Sysmex XE-2100 (58589)
ANALYTE: Hemoglobin (2515)

TEST SYSTEM, ASSAY, EXAMINATION:

    ABX Diagnostics PENTRA 60 (04877)
    Bayer ADVIA 60 (08224)
    Becton Dickinson QBC STAR (08233)
    Nova Stat Profile M7 (43129)
    Radiometer ABL NPT7 Series Analyzers (55645)
    Sysmex XE-2100 (58589)
ANALYTE: Heparin Dose Response (HDR) (2539)

TEST SYSTEM, ASSAY, EXAMINATION:

    ITC HEMOCHRON Response (automated dosage calculations) (28602)
ANALYTE: Heparin Management Panel (HMP) (2578)

TEST SYSTEM, ASSAY, EXAMINATION:

    Cardiovascular Diagnostics Rapidpoint Accent System {Rapidpoint 
Analyzer/HMT/HTT/PRT} (10501)
ANALYTE: Platelet Count (4908)

TEST SYSTEM, ASSAY, EXAMINATION:

    ABX Diagnostics PENTRA 60 (04877)
    Abbott CELL-DYN 4000 {ImmunoPlt (CD61) Assay} (04873)
    Bayer ADVIA 60 (08224)
    Becton Dickinson QBC STAR (08233)
    Sysmex R-3500 (58586)
    Sysmex XE-2100 (58589)
ANALYTE: Platelet Glycoprotein IIb/IIIa Receptor Blockade (4989)

TEST SYSTEM, ASSAY, EXAMINATION:

    Accumetrics Ultegra System {Rapid Platelet Function Assay} (04871)
ANALYTE: Prothrombin Time (PT) (4922)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)
    Dade Behring BFT II (13594)
    Dade Behring Coagulation System (BCS) (13608)
    ITC HEMOCHRON Response (28578)
    Pacific Hemostasis ThromboScreen 400C (49231)
    Sysmex CA-1000 (58604)
    Sysmex CA-5000 (58605)
    Sysmex CA-6000 (58606)
ANALYTE: Red Blood Cell Count (Erythrocyte Count) (RBC) (5502)

TEST SYSTEM, ASSAY, EXAMINATION:

    ABX Diagnostics PENTRA 60 (04877)
    Bayer ADVIA 60 (08224)
    Sysmex R-3500 (58586)
    Sysmex XE-2100 (58589)
ANALYTE: Red Blood Cells, Nucleated (5526)

TEST SYSTEM, ASSAY, EXAMINATION:

    Applied Imaging WINSCAN (04889)
    Sysmex XE-2100 (58589)
ANALYTE: Reptilase Time (5521)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Behring Coagulation System (BCS) (13608)
    Dade Behring Sysmex CA-500 Series (13548)
    Pacific Hemostasis ThromboScreen 400C (49231)
    Sysmex CA-6000 (58606)
    TOA Medical Electronics CA-6000 (61283)
ANALYTE: Reticulocyte Count (5506)

TEST SYSTEM, ASSAY, EXAMINATION:

    Coulter EPICS XL System {ReticONE

[[Page 25806]]

System} (10490)
    Sysmex R-3500 (58586)
    Sysmex XE-2100 (58589)
ANALYTE: Reticulocyte, Immature fraction (5525)

TEST SYSTEM, ASSAY, EXAMINATION:

    Sysmex R-3500 (58586)
    Sysmex XE-2100 (58589)
ANALYTE: Semen (5822)

TEST SYSTEM, ASSAY, EXAMINATION:

    Embryotech Laboratories FertilMARQ (16195)
ANALYTE: Thrombin Time (6105)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)
    Dade Behring Coagulation System (BCS) (13608)
    ITC HEMOCHRON Response (28578)
    ITC HEMOCHRON Response {HEMOCHRON HNTT} (28579)
    ITC HEMOCHRON Response {HEMOCHRON HiTT} (28580)
    Pacific Hemostasis ThromboScreen 400C (49231)
    Sysmex CA-1000 (58604)
    Sysmex CA-5000 (58605)
    Sysmex CA-6000 (58606)
ANALYTE: White Blood Cell Count (Leukocyte Count) (WBC) (7002)

TEST SYSTEM, ASSAY, EXAMINATION:

    ABX Diagnostics PENTRA 60 (04877)
    Bayer ADVIA 60 (08224)
    Becton Dickinson QBC STAR (08233)
    Sysmex XE-2100 (58589)
ANALYTE: White Blood Cell Differential (WBC Diff) (7001)

TEST SYSTEM, ASSAY, EXAMINATION:

    ABX Diagnostics PENTRA 60 (04877)
    Bayer ADVIA 60 (08224)
    Becton Dickinson QBC STAR (08233)
    Sysmex XE-2100 (58589)
ANALYTE: von Willebrand Factor (6708)

TEST SYSTEM, ASSAY, EXAMINATION:

    Instrumentation Laboratory IL ACL 6000 (28454)
    Instrumentation Laboratory IL ACL 7000 (28487)
    Instrumentation Laboratory IL ACL Futura System (28395)
SPECIALITY/SUBSPECIALITY: Immunohematology
ANALYTE: ABO group--RBC (0402)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dominion Biologicals NOVACLONE Anti-A, -B, -A+B (slide, tube) 
(13291)
SPECIALITY/SUBSPECIALITY: Mycology
ANALYTE: Yeast, Candida only (7603)

TEST SYSTEM, ASSAY, EXAMINATION:

    Biomed Diagnostics InTray COLOREX YEAST (08230)
SPECIALITY/SUBSPECIALITY: Toxicology / TDM
ANALYTE: Acetaminophen (0406)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Amikacin (0425)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Amphetamines (0428)

TEST SYSTEM, ASSAY, EXAMINATION:

    American BioMedica Rapid Drug Screen 9 Panel (04870)
    LifeSign Status DS THC/OPI/COC/AMP/BZO/BAR/TCA/PCP (37154)
    Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9177) 
(49222)
    Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9178) 
(49221)
    Princeton BioMeditech AccuSign DOA 8 THC/OPI/COC/AMP/BZO/BAR/TCA/
PCP (49217)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics OnTrak TesTcup-er (55635)
    Syntron Bioresearch QuikStrip DrugCheck X Multidrug Screening 
Device (58587)
ANALYTE: Barbiturates (0701)

TEST SYSTEM, ASSAY, EXAMINATION:

    American BioMedica Rapid Drug Screen 9 Panel (04870)
    LifeSign Status DS THC/OPI/COC/AMP/BZO/BAR/TCA/PCP (37154)
    Princeton BioMeditech AccuSign DOA 3 BAR/BZO/PCP (49216)
    Princeton BioMeditech AccuSign DOA 8 THC/OPI/COC/AMP/BZO/BAR/TCA/
PCP (49217)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Hitachi 717 {STC Auto-Lyte} (55638)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics OnTrak TesTcup-er (55635)
    Roche Diagnostics OnTrak TesTstik for Barbiturates (55636)
    Syntron Bioresearch QuikStrip DrugCheck X Multidrug Screening 
Device (58587)
ANALYTE: Benzodiazepines (0702)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott AxSYM (04532)
    American BioMedica Rapid Drug Screen 9 Panel (04870)
    LifeSign Status DS THC/OPI/COC/AMP/BZO/BAR/TCA/PCP (37154)
    Princeton BioMeditech AccuSign DOA 3 BAR/BZO/PCP (49216)
    Princeton BioMeditech AccuSign DOA 8 THC/OPI/COC/AMP/BZO/BAR/TCA/
PCP (49217)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Hitachi 717 {STC Auto-Lyte} (55638)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics OnTrak TesTcup-er (55635)
    Roche Diagnostics OnTrak TesTstik for Benzodiazepines (55637)
    Syntron Bioresearch QuikStrip DrugCheck X Multidrug Screening 
Device (58587)
ANALYTE: Cannabinoids (THC) (1009)

TEST SYSTEM, ASSAY, EXAMINATION:

    Abbott AxSYM (04532)
    American BioMedica Rapid Drug Screen 3-Panel Test for Coc/THC/
Opiates (04885)
    American BioMedica Rapid Drug Screen 9 Panel (04870)
    Drug Detection Devices Ltd DrugScreen Dip Marijuana Test (13565)
    Drug Detection Devices Ltd SCREENERS Marijuana Test (13566)
    LifeSign Status DS THC/OPI/COC/AMP/BZO/BAR/TCA/PCP (37154)
    LifeSign Status Stik THC/OPI/COC/AMPor MET (37155)
    Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9177) 
(49222)

[[Page 25807]]

    Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9178) 
(49221)
    Princeton BioMeditech AccuSign DOA 3 THC/OPI/COC (49215)
    Princeton BioMeditech AccuSign DOA 8 THC/OPI/COC/AMP/BZO/BAR/TCA/
PCP (49217)
    Redwood Biotech Redi-Screen (55633)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Hitachi 912 (55624)
    Sun Biomedical Laboratories Visualine V Coc/Opiates/THC/Met/PCP 
(58590)
    Syntron Bioresearch QuikStrip DrugCheck X Multidrug Screening 
Device (58587)
ANALYTE: Carbamazepine (1010)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS Plus (07795)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Carboxyhemoglobin (1012)

TEST SYSTEM, ASSAY, EXAMINATION:

Radiometer ABL NPT7 Series Analyzers (55645)
ANALYTE: Cocaine Metabolites (1023)

TEST SYSTEM, ASSAY, EXAMINATION:

    American BioMedica Rapid Drug Screen 3-Panel Test for Coc/THC/
Opiates (04885)
    American BioMedica Rapid Drug Screen 9 Panel (04870)
    LifeSign Status DS THC/OPI/COC/AMP/BZO/BAR/TCA/PCP (37154)
    LifeSign Status Stik THC/OPI/COC/AMPor MET (37155)
    Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9177) 
(49222)
    Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9178) 
(49221)
    Princeton BioMeditech AccuSign DOA 3 THC/OPI/COC (49215)
    Princeton BioMeditech AccuSign DOA 8 THC/OPI/COC/AMP/BZO/BAR/TCA/
PCP (49217)
    Redwood Biotech Redi-Screen (55633)
    Redwood Biotech Redi-Test Cocaine (55630)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Hitachi 717 {STC Auto-Lyte} (55638)
    Roche Diagnostics Hitachi 912 (55624)
    Roche Diagnostics OnTrak TesTcup-er (55635)
    Sun Biomedical Laboratories Visualine V Coc/Opiates/THC/Metamph/PCP 
(58590)
    Syntron Bioresearch QuikStrip DrugCheck X Multidrug Screening 
Device (58587)
ANALYTE: Digitoxin (1303)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Digoxin (1304)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Ethanol (Alcohol) (1608)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Gentamicin (2202)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Lidocaine (3710)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Lithium (3712)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Lysergic Acid Diethylamide (LSD) (3715)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Methadone (4003)

TEST SYSTEM, ASSAY, EXAMINATION:

    Forefront Diagnostics InstaCheck Drug Screen Methadone (19042)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Hitachi 912 (55624)
ANALYTE: Methamphetamine/Amphetamine (4036)

TEST SYSTEM, ASSAY, EXAMINATION:

    LifeSign Status Stik THC/OPI/COC/AMPor MET (37155)
ANALYTE: Methamphetamines (4004)

TEST SYSTEM, ASSAY, EXAMINATION:

    American BioMedica Rapid Drug Screen 9 Panel (04870)
    Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9178) 
(49221)
    Redwood Biotech Redi-Screen (55633)
    Sun Biomedical Laboratories Visualine V Coc/Opiates/THC/Met/PCP 
(58590)
    Syntron Bioresearch QuikStrip DrugCheck X Multidrug Screening 
Device (58587)
ANALYTE: Methaqualone (4005)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Morphine (4020)

TEST SYSTEM, ASSAY, EXAMINATION:

    Forefront Diagnostics InstaCheck Drug Screen Morphine 2000 (19043)
    Roche Diagnostics OnTrak TesTcup-er (55635)
ANALYTE: N-Acetylprocainamide (NAPA) (4301)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Opiates (4601)

TEST SYSTEM, ASSAY, EXAMINATION:

    American BioMedica Rapid Drug Screen 3-Panel Test for Coc/THC/

[[Page 25808]]

Opiates (04885)
    American BioMedica Rapid Drug Screen 9 Panel (04870)
    LifeSign Status DS THC/OPI/COC/AMP/BZO/BAR/TCA/PCP (37154)
    LifeSign Status Stik THC/OPI/COC/AMPor MET (37155)
    Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9177) 
(49222)
    Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9178) 
(49221)
    Princeton BioMeditech AccuSign DOA 3 THC/OPI/COC (49215)
    Princeton BioMeditech AccuSign DOA 8 THC/OPI/COC/AMP/BZO/BAR/TCA/
PCP (49217)
    Redwood Biotech Redi-Screen (55633)
    Redwood Biotech Redi-Test Opiates (55631)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Sun Biomedical Laboratories Visualine V Coc/Opiates/THC/Met/PCP 
(58590)
    Syntron Bioresearch QuikStrip DrugCheck X Multidrug Screening 
Device (58587)
ANALYTE: Phencyclidine (PCP) (4901)

TEST SYSTEM, ASSAY, EXAMINATION:

    American BioMedica Rapid Drug Screen 9 Panel (04870)
    Bionike AQ Phencyclidine (PCP) Test (08244)
    LifeSign Status DS THC/OPI/COC/AMP/BZO/BAR/TCA/PCP (37154)
    Phamatech QuickScreen Pro Multi Drug Screening Test (Model 9177) 
(49222)
    Princeton BioMeditech AccuSign DOA 3 BAR/BZO/PCP (49216)
    Princeton BioMeditech AccuSign DOA 8 THC/OPI/COC/AMP/BZO/BAR/TCA/
PCP (49217)
    Redwood Biotech Redi-Screen (55633)
    Redwood Biotech Redi-Test PCP (55632)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Hitachi 717 {STC Auto-Lyte} (55638)
    Roche Diagnostics Hitachi 912 (55624)
    Sun Biomedical Laboratories Visualine V Coc/Opiates/THC/Met/PCP 
(58590)
    Syntron Bioresearch QuikStrip DrugCheck X Multidrug Screening 
Device (58587)
    TCPI One Step Urine Drug of Abuse Phencyclidine (PCP) (61453)
ANALYTE: Phenobarbital (4902)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Phenytoin (4903)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Phenytoin, Free (4904)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Primidone (4912)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Procainamide (4913)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Propoxyphene (4917)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
    Roche Diagnostics Hitachi 912 (55624)
ANALYTE: Quinidine (5202)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Salicylates (5801)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Theophylline (6104)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Tobramycin (6112)

TEST SYSTEM, ASSAY, EXAMINATION:

    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Tricyclic Antidepressants (6117)

TEST SYSTEM, ASSAY, EXAMINATION:

    American BioMedica Rapid Drug Screen 9 Panel (04870)
    LifeSign Status DS THC/OPI/COC/AMP/BZO/BAR/TCA/PCP (37154)
    Princeton BioMeditech AccuSign DOA 8 THC/OPI/COC/AMP/BZO/BAR/TCA/
PCP (49217)
ANALYTE: Valproic Acid (6701)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Behring OPUS Magnum (07794)
    Behring OPUS Plus (07795)
    Dade Behring Dimension AR (13517)
    Dade Behring Dimension RxL (13519)
    Dade Dimension ES (13420)
    Dade Dimension XL (13422)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Valproic Acid, Free (6702)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
ANALYTE: Vancomycin (6703)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bayer ADVIA IMS (08254)
    Roche Diagnostics Cobas INTEGRA 400 (55634)
    Roche Diagnostics Cobas INTEGRA 700 (55643)
SPECIALITY/SUBSPECIALITY: Virology
ANALYTE: Adenovirus (0410)

[[Page 25809]]

TEST SYSTEM, ASSAY, EXAMINATION:

    SA Scientific SAS Adeno Test (direct Ag/visual) (58585)
ANALYTE: Influenza A/B (2835)

TEST SYSTEM, ASSAY, EXAMINATION:

    Quidel QuickVue Influenza Test (52119)
ANALYTE: Rotavirus (5509)

TEST SYSTEM, ASSAY, EXAMINATION:

    SA Scientific SAS Rotavirus Test (direct Ag/visual) (58583)
COMPLEXITY: HIGH
SPECIALITY/SUBSPECIALITY: Bacteriology
ANALYTE: Chlamydia (1016)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels Chlamydia EIA (direct Ag/spectrophotometric) 
(28586)
    INTRACEL Bartels Chlamydiae FA Monoclonal (including cell culture) 
(28587)
    INTRACEL Bartels Chlamydiae Immunoperoxidase (including cell 
culture) (28588)
    Roche Diagnostics AMPLICOR CT/NG Test for Chlamydia trachomatis 
(55669)
ANALYTE: Clostridium difficile (1022)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels C. difficile Toxin A EIA (28576)
    INTRACEL Bartels C. difficile Toxin A EIA (direct Ag) (28584)
    INTRACEL Bartels Cytotoxicity Assay for C. difficile (direct Ag) 
(28589)
    Meridian Diagnostics Premier Toxins A & B (direct antigen/
spectrophotometric) (40345)
    Meridian Diagnostics Premier Toxins A & B (direct antigen/visual) 
(40344)
ANALYTE: Escherichia coli (1604)

TEST SYSTEM, ASSAY, EXAMINATION:

    Denka Seiken VTEC-RPLA ``SEIKEN'' (including culture) (13595)
ANALYTE: Haemophilus (2577)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Behring MicroScan MICroSTREP plus (13597)
ANALYTE: Neisseria gonorrhoeae (4302)

TEST SYSTEM, ASSAY, EXAMINATION:

    Roche Diagnostics COBAS AMPLICOR Analyzer (55253)
ANALYTE: Staphylococcus (5807)

TEST SYSTEM, ASSAY, EXAMINATION:

    Oxoid DrySpot Staphytect Plus (including culture) (46322)
ANALYTE: Streptococcus, group A (5810)

TEST SYSTEM, ASSAY, EXAMINATION:

    LifeSign Streptolex STAT (including culture) (37152)
ANALYTE: Streptococcus, group B (5811)

TEST SYSTEM, ASSAY, EXAMINATION:

    LifeSign Streptolex STAT (including culture) (37152)
ANALYTE: Streptococcus, group C (5812)

TEST SYSTEM, ASSAY, EXAMINATION:

    LifeSign Streptolex STAT (including culture) (37152)
ANALYTE: Streptococcus, group F (5814)

TEST SYSTEM, ASSAY, EXAMINATION:

    LifeSign Streptolex STAT (including culture) (37152)
ANALYTE: Streptococcus, group G (5815)

TEST SYSTEM, ASSAY, EXAMINATION:

    LifeSign Streptolex STAT (including culture) (37152)
SPECIALITY/SUBSPECIALITY: Endocrinology
ANALYTE: Calcitonin (1041)

TEST SYSTEM, ASSAY, EXAMINATION:

    KMI Diagnostics Calcitonin ELISA (34115)
ANALYTE: Cortisol, Urine (extraction procedure) (1095)

TEST SYSTEM, ASSAY, EXAMINATION:

    Nichols Institute Advantage Chemiluminescence System (43122)
ANALYTE: Thyroid Stimulating Hormone (TSH) (6106)

TEST SYSTEM, ASSAY, EXAMINATION:

    BioCheck Thyroid Stimulating Hormone (TSH) EIA (08248)
ANALYTE: Thyroid Stimulating Hormone--high sens. (TSH-HS) (6108)

TEST SYSTEM, ASSAY, EXAMINATION:

    BioCheck Sensitive Thyroid Stimulating Hormone (S-TSH) EIA (08251)
ANALYTE: Thyroxine (T4) (6109)

TEST SYSTEM, ASSAY, EXAMINATION:

    BioCheck Total Thyroxine (T4) EIA (08249)
    Biotecx Laboratories OptiCoat T4 EIA (08221)
ANALYTE: Triiodothyronine (T3) (6119)

TEST SYSTEM, ASSAY, EXAMINATION:

    BioCheck Triiodothyronine (T3) EIA (08250)
SPECIALITY/SUBSPECIALITY: General Chemistry
ANALYTE: Alpha-Fetoprotein--Amniotic Fluid (0484)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman ACCESS Immunoassay System (07914)
ANALYTE: Alpha-Fetoprotein--Maternal Serum (0423)

TEST SYSTEM, ASSAY, EXAMINATION:

    Beckman ACCESS Immunoassay System (07914)
ANALYTE: Carbon Dioxide, Isotope 13 (1150)

TEST SYSTEM, ASSAY, EXAMINATION:

    Finnigan BreathMAT Plus Isotope Ratio Mass Spectrometer {Metabolic 
Solutions Ez-HBT Helicobacter Blood Test} (19054)
ANALYTE: Creatine Kinase Isoenzymes (CK Isoenzymes) (1052)

TEST SYSTEM, ASSAY, EXAMINATION:

    Sebia HYDRASYS {Hydragel 7/15/30 ISO-CK} (58597)
ANALYTE: Creatine Kinase MB Fraction (CKMB) (1002)

TEST SYSTEM, ASSAY, EXAMINATION:

    Randox Laboratories CK-MB NAC-activated Test Kit (55159)
ANALYTE: Ferritin (1902)

TEST SYSTEM, ASSAY, EXAMINATION:

    BioCheck Ferritin ELISA (08232)
    Johnson & Johnson CDL Amerlite Analyzer (31016)
ANALYTE: Fructosamine (1914)

[[Page 25810]]

TEST SYSTEM, ASSAY, EXAMINATION:

    Pointe Scientific Fructosamine (49227)
ANALYTE: Galactose, Total (2223)

TEST SYSTEM, ASSAY, EXAMINATION:

    Quantase Total Galactose (Newborn) Screening Assay (52120)
ANALYTE: Galactose-1-Phosphate Uridyl Transferase (2215)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad CODA Neonatal GALT (08255)
ANALYTE: Homocysteine (2574)

TEST SYSTEM, ASSAY, EXAMINATION:

    Bio-Rad CDM System {Bio-Rad HPLC} (07792)
    Drew Scientific DS30 Analyzer {DS30 Hcy Homocysteine Assay} (13593)
ANALYTE: Leucine (3749)

TEST SYSTEM, ASSAY, EXAMINATION:

    Wallac Neonatal Leucine Test Kit (70237)
ANALYTE: Lipoprotein Fractions (3720)

TEST SYSTEM, ASSAY, EXAMINATION:

    Helena Laboratories REP/REP3 Cholesterol Profile Template-30 
(25307)
    Helena Laboratories REP/REP3 Vis Cholesterol (25306)
    Sebia HYDRASYS {Hydragel 7/15/30 LIPO} (58603)
    Sebia Hydragel -Mini LIPO/LIPO Kit (manual) (58602)
ANALYTE: Protein Fractions (4920)

TEST SYSTEM, ASSAY, EXAMINATION:

    Sebia HYDRASYS {Hydragel 5 Proteinurie} (58595)
    Sebia HYDRASYS {Hydragel 7/15 HR} (58598)
    Sebia Hydragel -Mini HR/HR Kit (manual) (58600)
    Sebia Hydragel -Mini HR/HR Urine Kit (manual) (58601)
    Sebia Hydragel Proteinurie Kit (manual) (58599)
ANALYTE: Thyroglobulin (6124)

TEST SYSTEM, ASSAY, EXAMINATION:

    Kronus OptiQuant Thyroglobulin Kit (34116)
ANALYTE: Transferrin, carbohydrate-deficient (6165)

TEST SYSTEM, ASSAY, EXAMINATION:

    Axis CDT Turbidometric Immunoassay (04887)
    SPECIALITY/SUBSPECIALITY: General Immunology
ANALYTE: Anti-B2 Glycoprotein I (apolipoprotein H) (B2 GPI) (0529)

TEST SYSTEM, ASSAY, EXAMINATION:

    Hemagen VIRGO Beta 2 Glycoprotein I (B2GPI) IgA (25298)
    Hemagen VIRGO Beta 2 Glycoprotein I (B2GPI) IgG (25296)
    Hemagen VIRGO Beta 2 Glycoprotein I (B2GPI) IgM (25297)
    Reaads Medical Products IgA Anti-Beta 2 Glycoprotein I Semi-quant 
Test Kit (55642)
    Reaads Medical Products IgG Anti-Beta 2 Glycoprotein I Semi-quant 
Test Kit (55640)
Reaads Medical Products IgM Anti-Beta 2 Glycoprotein I Semi-quant Test 
Kit (55641)
ANALYTE: Anti-Cardiolipin Antibodies (0434)

TEST SYSTEM, ASSAY, EXAMINATION:

    Cogent Diagnostics AUTOSTAT II Anti-Cardiolipin IgG (10497)
    Cogent Diagnostics AUTOSTAT II Anti-Cardiolipin IgM (10496)
ANALYTE: Anti-Centromere Antibodies (0487)

TEST SYSTEM, ASSAY, EXAMINATION:

    Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA, RNP, Sm, 
SS-A/Ro, SS-B/La, Scl-70, Centromere, Jo-1) (49229)
ANALYTE: Anti-DNA Antibodies (0435)

TEST SYSTEM, ASSAY, EXAMINATION:

    Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA, RNP, Sm,SS-
A/Ro, SS-B/La, Scl-70, Centromere, Jo-1) (49229)
    Stellar Bio Systems Indirect Fluorescence Assay for Anti-native DNA 
IgG (58593)
    The Binding Site BINDAZYME Anti-dsDNA EIA (61461)
ANALYTE: Anti-Endomysial Antibodies (EMA) (0497)

TEST SYSTEM, ASSAY, EXAMINATION:

    MeDiCa AEmA Test Kit (40335)
ANALYTE: Anti-Gliadin Antibodies (0528)

TEST SYSTEM, ASSAY, EXAMINATION:

    Cogent Diagnostics AUTOSTAT II Anti-Gliadin IgA (10492)
    Cogent Diagnostics AUTOSTAT II Anti-Gliadin IgG (10489)
ANALYTE: Anti-Glomerular Basement Membrane (GBM) Antibodies (0524)

TEST SYSTEM, ASSAY, EXAMINATION:

    Cogent Diagnostics AUTOSTAT II Anti-GBM (10486)
    Hycor HY-TEC Anti-GBM ELISA (manual) (25302)
ANALYTE: Anti-Jo-1 (0438)

TEST SYSTEM, ASSAY, EXAMINATION:

    Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA, RNP, Sm, 
SS-A/Ro, SS-B/La, Scl-70, Centromere, Jo-1) (49229)
    Trinity Biotech Captia ENA Profile ELISA (Sm, Sm/RNP, SSA/Ro, SSB/
La, Scl-70, Jo-1) (61462)
ANALYTE: Anti-Myeloperoxidase (MPO) Antibodies (0505)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diamedix Immunosimplicity (Is)-MPO (P-ANCA) IgG (manual/
qualitative) (13587)
    Diamedix Immunosimplicity (Is)-MPO (P-ANCA) IgG (manual/semi-
quantitative) (13588)
ANALYTE: Anti-Nuclear Antibodies (ANA) (0441)

TEST SYSTEM, ASSAY, EXAMINATION:

    Pharmacia & Upjohn Varelisa ReCombi ANA Screen (dsDNA, RNP, Sm, SS-
A/Ro, SS-B/La, Scl-70, Centromere, Jo-1) (49228)
    RhiGene ANA ELISA TEST SYSTEM (55670)
    Stellar Bio Systems Indirect Fluorescence Assay for IgG ANA HEp2 
(58592)
ANALYTE: Anti-Parietal Cell Antibodies (0442)

TEST SYSTEM, ASSAY, EXAMINATION:

    Cogent Diagnostics AUTOSTAT II Anti-GPC (10487)
    Hycor HY-TEC Anti-GPC ELISA (manual) (25300)
ANALYTE: Anti-Proteinase-3 (PR-3) Antibodies (0525)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diamedix Immunosimplicity (Is)-anti-PR-3 (C-ANCA) IgG (manual/
qualitative) (13584)
    Diamedix Immunosimplicity (Is)-anti-PR-3 (C-ANCA) IgG (manual/semi-
quantitative) (13585)
ANALYTE: Anti-RNP (Ribonucleoprotein) (0443)

TEST SYSTEM, ASSAY, EXAMINATION:

    Pharmacia & Upjohn Varelisa RNP

[[Page 25811]]

Antibodies EIA (qualitative) (49223)
    Pharmacia & Upjohn Varelisa RNP Antibodies EIA (semi-quantitative) 
(49224)
    Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA,RNP,Sm,SS-A/
Ro,SS-B/La,Scl-70,Centromere,Jo-1) (49229)
ANALYTE: Anti-RNP-Sm Antibodies (0502)

TEST SYSTEM, ASSAY, EXAMINATION:

    Micro Detect MDI Sm/RNP Test (40340)
    Trinity Biotech Captia ENA Profile ELISA (Sm,Sm/RNP,SSA/Ro,SSB/
La,Scl-70,Jo-1) (61462)
ANALYTE: Anti-SS-A/Ro (0446)

TEST SYSTEM, ASSAY, EXAMINATION:

    Micro Detect MDI SS-A Test (40339)
    Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA, RNP, Sm, 
SS-A/Ro, SS-B/La, Scl-70,Centromere,Jo-1) (49229)
    Trinity Biotech Captia ENA Profile ELISA (Sm, Sm/RNP, SSA/Ro, SSB/
La, Scl-70, Jo-1) (61462)
ANALYTE: Anti-SS-B/La (0447)

TEST SYSTEM, ASSAY, EXAMINATION:

    Micro Detect MDI SS-B Test (40343)
    Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA, RNP, Sm, 
SS-A/Ro, SS-B/La, Scl-70, Centromere, Jo-1) (49229)
    Trinity Biotech Captia ENA Profile ELISA (Sm, Sm/RNP, SSA/Ro, SSB/
La, Scl-70, Jo-1) (61462)
ANALYTE: Anti-Scl-70 (0448)

TEST SYSTEM, ASSAY, EXAMINATION:

    Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA, RNP, Sm, 
SS-A/Ro, SS-B/La, Scl-70, Centromere, Jo-1) (49229)
    Trinity Biotech Captia ENA Profile ELISA (Sm, Sm/RNP, SSA/Ro, SSB/
La, Scl-70, Jo-1) (61462)
ANALYTE: Anti-Sm (Smith) (0450)

TEST SYSTEM, ASSAY, EXAMINATION:

    Micro Detect MDI Sm Test (40341)
    Pharmacia & Upjohn Varelisa ReCombi ANA Profile (dsDNA, RNP, Sm, 
SS-A/Ro, SS-B/La, Scl-70, Centromere, Jo-1) (49229)
    Trinity Biotech Captia ENA Profile ELISA (Sm, Sm/RNP, SSA/Ro, SSB/
La, Scl-70, Jo-1) (61462)
ANALYTE: Anti-Thyroglobulin Antibodies (0453)

TEST SYSTEM, ASSAY, EXAMINATION:

    BRAHMS Diagnostica DYNOtest Anti-Tg (08243)
    Diamedix Immunosimplicity (Is)-anti-TG IgG (manual/qualitative) 
(13591)
    Diamedix Immunosimplicity (Is)-anti-TG IgG (manual/quantitative) 
(13592)
ANALYTE: Anti-Thyroid Peroxidase (TPO) Antibodies (0527)

TEST SYSTEM, ASSAY, EXAMINATION:

    BRAHMS Diagnostica DYNOtest Anti-TPO (08242)
    Pharmacia & Upjohn Varelisa TPO Antibodies EIA (qualitative) 
(49225)
    Pharmacia & Upjohn Varelisa TPO Antibodies EIA (quantitative) 
(49226)
ANALYTE: Anti-Tissue Transglutaminase (tTG) (0546)

TEST SYSTEM, ASSAY, EXAMINATION:

    IMMCO Diagnostics ImmuLisa Anti-Tissue Transglutaminase (tTG) Ab 
ELISA (qualitative) (28569)
    IMMCO Diagnostics ImmuLisa Anti-Tissue Transglutaminase (tTG) Ab 
ELISA (semi-quantitative) (28570)
    The Binding Site BINDAZYME Anti-Transglutaminase IgA EIA (61463)
ANALYTE: Cerebrospinal Fluid Protein Fractions (1057)

TEST SYSTEM, ASSAY, EXAMINATION:

    Sebia HYDRASYS {Hydragel 6 CSF} (58596)
    Sebia HYDRASYS {Hydragel 7/15 HR} (58598)
    Sebia Hydragel -Mini HR/HR Kit (manual) (58600)
ANALYTE: Complement, Total (1046)

TEST SYSTEM, ASSAY, EXAMINATION:

    The Binding Site Total Haemolytic Complement Kit (61450)
ANALYTE: Epstein-Barr virus Antibodies (1603)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diamedix Immunosimplicity (Is)-EBNA-1 IgM (manual) (13574)
    Diamedix Immunosimplicity (Is)-EBV-EA-D IgG (manual) (13564)
    Diamedix Immunosimplicity (Is)-EBV-EA-D IgM (manual) (13576)
    Diamedix Immunosimplicity (Is)-EBV-VCA IgM (manual) (13578)
    GenBio ImmunoWELL EBNA IgG Quantitative Test (22254)
    GenBio ImmunoWELL EBV VCA IgG Quantitative Test (22255)
    GenBio ImmunoWELL EBV VCA IgM Quantitative Test (22256)
    Quest International SeraQuest EB NA IgG (qualitative) (52117)
    Quest International SeraQuest EB NA IgG (semi-quantitative) (52118)
    Quest International SeraQuest EB VCA IgG (qualitative) (52115)
    Quest International SeraQuest EB VCA IgG (semi-quantitative) 
(52116)
    Quest International SeraQuest EB VCA IgM (52114)
ANALYTE: HLA-DR (2576)

TEST SYSTEM, ASSAY, EXAMINATION:

    bioMerieux Vitek HLA-DR oligo-detection Kit (08253)
ANALYTE: Helicobacter pylori Antibodies (2513)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diamedix Immunosimplicity (Is)-H. pylori IgG (manual) (13583)
ANALYTE: Immunoglobulins IgE (2805)

TEST SYSTEM, ASSAY, EXAMINATION:

    BioCheck Immunoglobulin E (IgE) ELISA (08231)
    Hycor Total IgE RIA (25315)
ANALYTE: Legionella pneumophilia Serogroup 1 Antigen (3778)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels Legionella Urinary Antigen ELISA (direct Ag/
spectrophotometric) (28575)
    INTRACEL Bartels Legionella Urinary Antigen ELISA (direct Ag/
visual) (28574)
ANALYTE: Lyme Disease Antibodies (Borrelia burgdorferi Abs) (3714)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diamedix Immunosimplicity (Is)-anti-Borrelia burgdorferi IgG/IgM 
(manual) (13572)
    Diamedix Immunosimplicity (Is)-anti-Borrelia burgdorferi IgM 
(manual) (13570)
ANALYTE: Lymphocytes, CD19 (3759)

TEST SYSTEM, ASSAY, EXAMINATION:

    Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-
PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 
(10495)
ANALYTE: Lymphocytes, CD3 (3760)

TEST SYSTEM, ASSAY, EXAMINATION:

    Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-
PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 
(10495)
ANALYTE: Lymphocytes, CD3-/CD56+ (3783)

[[Page 25812]]

TEST SYSTEM, ASSAY, EXAMINATION:

    Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-
PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 
(10495)
ANALYTE: Lymphocytes, CD3/CD4 (3766)

TEST SYSTEM, ASSAY, EXAMINATION:

    Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-
PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 
(10495)
ANALYTE: Lymphocytes, CD3/CD8 (3767)

TEST SYSTEM, ASSAY, EXAMINATION:

    Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-
PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 
(10495)
ANALYTE: Lymphocytes, CD4 (3761)

TEST SYSTEM, ASSAY, EXAMINATION:

    Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-
PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 
(10495)
ANALYTE: Lymphocytes, CD8 (3764)

TEST SYSTEM, ASSAY, EXAMINATION:

    Coulter EPICS XL/tetraONE System {CD45-FITC/CD4-RD1/CD8-ECD/CD3-
PC5&CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5} (CYTO-STAT tetraCHROME) 
(10495)
ANALYTE: Mumps Antibodies (4007)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diamedix Immunosimplicity (Is)-Mumps IgG (manual) (13580)
ANALYTE: Rheumatoid Factor (RF) (5508)

TEST SYSTEM, ASSAY, EXAMINATION:

    Cogent Diagnostics AUTOSTAT II Rheumatoid Factor IgG (10498)
    Micro Detect MDI RF Test (40342)
ANALYTE: Treponema pallidum Antibodies (includes Reagin) (6115)

TEST SYSTEM, ASSAY, EXAMINATION:

    Avanti Polar Lipids VDRL Antigen Slide Test (04878)
ANALYTE: Varicella-Zoster Virus Antibodies (6704)

TEST SYSTEM, ASSAY, EXAMINATION:

    Light Diagnostics SimulFluor HSV/VZV IFA (direct antigen) (37161)
    Light Diagnostics SimulFluor HSV/VZV IFA (including culture) 
(37162)
SPECIALITY/SUBSPECIALITY: Hematology
ANALYTE: Activated Partial Thromboplastin Time (APTT) (0409)

TEST SYSTEM, ASSAY, EXAMINATION:

    Diagnostica Stago PTT-LT Test Kit (manual) (13312)
ANALYTE: Alpha-2-Antiplasmin (0463)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)
    Biopool Spectrolyse alpha-2-antiplasmin Kit (07602)
    Dade Behring Coagulation System (BCS) (13608)
    Sysmex CA-6000 (58606)
    TOA Medical Electronics CA-6000 (61283)
ANALYTE: Antithrombin III (ATIII) (0456)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)
    Chromogenix COACUTE Antithrombin R (manual) (10314)
    Pacific Hemostasis ThromboScreen 400C (49231)
    Sysmex CA-6000 (58606)
ANALYTE: Coagulation Factors (1044)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)
    Dade Behring Coagulation System (BCS) (13608)
    Dade Behring Sysmex CA-500 Series (13548)
    Pacific Hemostasis ThromboScreen 400C (49231)
    Sysmex CA-1000 (58604)
    Sysmex CA-5000 (58605)
    Sysmex CA-6000 (58606)
ANALYTE: Fibrinogen (1905)

TEST SYSTEM, ASSAY, EXAMINATION:

    Pacific Hemostasis ThromboScreen 400C (von Clauss methodology) 
(49232)
ANALYTE: Heparin (2518)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)
    Chromogenix COAMATIC Heparin (manual) (10500)
    Dade Behring Coagulation System (BCS) (13608)
    Dade Behring Sysmex CA-500 Series (13548)
    Helena Laboratories Chrom Z-Heparin (manual) (25238)
    Helena Laboratories PACKS-4 (25029)
    Pacific Hemostasis ThromboScreen 400C (49231)
    Sysmex CA-6000 (58606)
    TOA Medical Electronics CA-6000 (61283)
ANALYTE: Heparin Dose Response (HDR) (2539)

TEST SYSTEM, ASSAY, EXAMINATION:

    ITC HEMOCHRON Response (manual dosage calculations) (28603)
ANALYTE: Heparin, Low Molecular Weight (LMWH) (2558)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)
    Helena Laboratories Chrom Z-Heparin (manual) (25238)
    Helena Laboratories PACKS-4 (25029)
ANALYTE: Heparin/Protamine Titration (HPT) (2538)

TEST SYSTEM, ASSAY, EXAMINATION:

    ITC HEMOCHRON Response (28578)
ANALYTE: Lupus Anticoagulants (3728)

TEST SYSTEM, ASSAY, EXAMINATION:

    Dade Behring Coagulation System (BCS) (13608)
    Instrumentation Laboratory IL ACL Futura System {LAC Screen/
Confirm} (28601)
ANALYTE: Plasminogen (4907)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)
    Dade Behring Coagulation System (BCS) (13608)
    Sysmex CA-6000 (58606)
ANALYTE: Protamine Response Test (PRT) (4945)

TEST SYSTEM, ASSAY, EXAMINATION:

    ITC HEMOCHRON Response (28578)
ANALYTE: Protein C (4929)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)

[[Page 25813]]

    Dade Behring Coagulation System (BCS) (13608)
    Dade Behring Sysmex CA-500 Series (13548)
    Sysmex CA-6000 (58606)
    TOA Medical Electronics CA-6000 (61283)
ANALYTE: Protein S (4930)

TEST SYSTEM, ASSAY, EXAMINATION:

    American Bioproducts STA-R Analyzer (04875)
    Reaads Medical Products Monoclonal Free Protein S Antigen Test Kit 
(55639)
SPECIALITY/SUBSPECIALITY: Mycobacteriology
ANALYTE: Mycobacteria (4024)

TEST SYSTEM, ASSAY, EXAMINATION:

    Difco ESP Culture System II (13399)
ANALYTE: Mycobacterium tuberculosis complex (4015)

TEST SYSTEM, ASSAY, EXAMINATION:

    Gen-Probe AMPLIFIED Mycobacterium Tuberculosis Direct (MTD) Test 
(22276)
SPECIALITY/SUBSPECIALITY: Parasitology
ANALYTE: Pneumocystis (4926)

TEST SYSTEM, ASSAY, EXAMINATION:

    Light Diagnostics Pneumocystis carinii DFA (37158)
SPECIALITY/SUBSPECIALITY: Virology
ANALYTE: Adenovirus (0410)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels Viral Respiratory Kit (including cell culture) 
(28600)
    SA Scientific SAS Adeno Test (including cell culture) (58584)
ANALYTE: Cytomegalovirus (1038)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels CINAKIT CMV Antigenemia (28568)
    INTRACEL Bartels CMV Immed. Early Ag IFA (including cell culture) 
(28585)
    INTRACEL Bartels Direct CMV DFA Kit (direct Ag) (28590)
    INTRACEL Bartels Direct CMV DFA Kit (including cell culture) 
(28591)
    Organon Teknika NucliSens CMV pp67 (46332)
ANALYTE: Herpes simplex (2529)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels HSV 1 & 2 FA Typing (including cell culture) 
(28592)
    INTRACEL Bartels HSV FA Bivalent DFA (including cell culture) 
(28593)
    INTRACEL Bartels HSV Immunoperoxidase Test (including cell culture) 
(28594)
    Light Diagnostics SimulFluor HSV 
1/2 IFA (direct antigen) (37159)
    Light Diagnostics SimulFluor HSV 
1/2 IFA (including culture) (37160)
    Light Diagnostics SimulFluor HSV/VZV IFA (direct antigen) (37161)
    Light Diagnostics SimulFluor HSV/VZV IFA (including culture) 
(37162)
ANALYTE: Influenza A (2828)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels PRIMA Influenza A EIA (direct Ag/
spectrophotometric) (28595)
    INTRACEL Bartels PRIMA Influenza A EIA (including cell culture) 
(28596)
    INTRACEL Bartels Viral Respiratory Kit (direct Ag) (28599)
    INTRACEL Bartels Viral Respiratory Kit (including cell culture) 
(28600)
ANALYTE: Influenza B (2829)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels Viral Respiratory Kit (direct Ag) (28599)
    INTRACEL Bartels Viral Respiratory Kit (including cell culture) 
(28600)
ANALYTE: Parainfluenza 1 (4959)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels Viral Respiratory Kit (direct Ag) (28599)
    INTRACEL Bartels Viral Respiratory Kit (including cell culture) 
(28600)
ANALYTE: Parainfluenza 2 (4960)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels Viral Respiratory Kit (including cell culture) 
(28600)
ANALYTE: Parainfluenza 3 (4961)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels Viral Respiratory Kit (direct Ag) (28599)
    INTRACEL Bartels Viral Respiratory Kit (including cell culture) 
(28600)
ANALYTE: Respiratory syncytial virus (5503)

TEST SYSTEM, ASSAY, EXAMINATION:

    INTRACEL Bartels RSV (FA) Test Kit (direct Ag) (28597)
    INTRACEL Bartels RSV (FA) Test Kit (including cell culture) (28598)
    INTRACEL Bartels Viral Respiratory Kit (direct Ag) (28599)
    INTRACEL Bartels Viral Respiratory Kit (including cell culture) 
(28600)
ANALYTE: Rotavirus (5509)

TEST SYSTEM, ASSAY, EXAMINATION:

    Eldan-Tech ROTA-dan Rapid Rotavirus EIA (direct Ag/
spectrophotometric) (16131)
    Eldan-Tech ROTA-dan Rapid Rotavirus EIA (direct Ag/visual) (16132)
COMPLEXITY: WAIVED
SPECIALITY/SUBSPECIALITY: Bacteriology
ANALYTE: Helicobacter pylori (2512)

TEST SYSTEM, ASSAY, EXAMINATION:

    Ballard Medical Products CLOtest (08223)
ANALYTE: Streptococcus, group A (5810)

TEST SYSTEM, ASSAY, EXAMINATION:

    Fisher HealthCare Sure-Vue Strep A (direct from throat swab) 
(19038)
    Remel RIM A.R.C. Strep A Test (direct from throat swab) (55687)
SPECIALITY/SUBSPECIALITY: Endocrinology
ANALYTE: Ovulation Test (LH) by Visual Color Comparison (9461)

TEST SYSTEM, ASSAY, EXAMINATION:

    Germaine Laboratories AimStep Ovulation (22271)
    Unipath ClearPlan Easy Ovulation Test (64052)
ANALYTE: Urine HCG by Visual Color Comparison Tests (9642)

TEST SYSTEM, ASSAY, EXAMINATION:

    ACON One Step Home Pregnancy Test (04881)
    ACON hCG Urine One Step Pregnancy Test Device (04882)
    CENOGENICS ACCUNATE-ONE STEP (10484)
    Fisher HealthCare Sure-Vue Serum/Urine hCG (19041)
    Fisher HealthCare Sure-Vue Serum/Urine hCG-STAT (19040)
    Fisher HealthCare Sure-Vue Urine hCG (19039)
    Germaine Laboratories AccuDip Home Pregnancy Test (22267)
    Germaine Laboratories AccuHome Pregnancy Test (22268)

[[Page 25814]]

    Germaine Laboratories AccuPlus Home Pregnancy Test (22269)
    Germaine Laboratories AimStick Home Pregnancy Test (22266)
    InBios InSure Pregnancy Test (28582)
    Remel RIM A.R.C. hCG Pregnancy Test (55673)
    Unipath ClearBlue Easy One Minute Pregnancy Test (64051)
    Unipath ClearPlan Easy Home Pregnancy Test (64050)
    Unipath ClearPlan Easy II Home Pregnancy Test (64053)
    Wampole Clearview EASY HCG (70235)
SPECIALITY/SUBSPECIALITY: General Chemistry
ANALYTE: Cholesterol (1020)

TEST SYSTEM, ASSAY, EXAMINATION:

    Polymer Technology Systems MTM BioScanner 1000 (for OTC use) 
(49196)
ANALYTE: Fecal Occult Blood (9191)

TEST SYSTEM, ASSAY, EXAMINATION:

    CENOGENICS TRI-SLIDE and SINGLE-SLIDE Stool Blood Test (10483)
    Immunostics Colon Alert (28567)
    Laboratory Diagnostics QUIK-CULT (37156)
ANALYTE: Fructosamine (1914)

TEST SYSTEM, ASSAY, EXAMINATION:

    LXN IN CHARGE Diabetes Control System (37150)
ANALYTE: Glucose Monitoring Devices (FDA Cleared/Home Use) (9221)

TEST SYSTEM, ASSAY, EXAMINATION:

    Clinical Diagnostics PocketLab II Blood Glucose Monitoring System 
(10482)
    Home Diagnostics Prestige LX Blood Glucose System (25295)
    LXN GO System (37157)
    LXN IN CHARGE Diabetes Control System (37150)
    MediSense Precision PCx Point of Care Mgmt System for Blood Glucose 
Testing (40332)
    TheraSense FreeStyle Blood Glucose Monitoring System (61451)
ANALYTE: HDL Cholesterol (2550)

TEST SYSTEM, ASSAY, EXAMINATION:

    Polymer Technology Systems BioScanner (for OTC use) (49233)
ANALYTE: Ketone, Blood (3403)

TEST SYSTEM, ASSAY, EXAMINATION:

    Polymer Technology Systems BioScanner (for OTC use) (49233)
SPECIALITY/SUBSPECIALITY: General Immunology
ANALYTE: Helicobacter pylori Antibodies (2513)

TEST SYSTEM, ASSAY, EXAMINATION:

    Applied Biotech SureStep H. pylori WB Test (whole blood) (04874)
    LifeSign Status H. pylori (for whole blood) (37151)
ANALYTE: Infectious Mononucleosis Antibodies (Mono) (2809)

TEST SYSTEM, ASSAY, EXAMINATION:

    Meridian Diagnostics ImmunoCard STAT! Mono (whole blood) (40333)
    Remel RIM A.R.C. Mono Test (whole blood) (55686)
SPECIALITY/SUBSPECIALITY: Hematology
ANALYTE: Erythrocyte Sedimentation Rate,nonautomated waived (9161)

TEST SYSTEM, ASSAY, EXAMINATION:

    Polymedco SEDIPLAST WESTERGREN ESR (49219)
    Polymedco SEDIPLAST WINTROBE ESR (49218)
SPECIALITY/SUBSPECIALITY: Urinalysis
ANALYTE: Urine Dipstick or Tablet Analytes, nonautomated (9641)

TEST SYSTEM, ASSAY, EXAMINATION:

    Germaine Laboratories AimStick 10-SG (22264)
    Germaine Laboratories AimStick US-2 (22263)
    Germaine Laboratories AimStick US-3 (22262)
    Germaine Laboratories AimStick US-9 (22265)
    International Newtech Develop. Urinalysis Reagent Strip (10 
Parameters) (28581)
    TCPI URI-TEST Protein in Urine (61454)

[FR Doc. 00-10876 Filed 5-2-00; 8:45 am]
BILLING CODE 4163-18-P