ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CHEK-STIX U.T.I. SELF-TEST

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GLUCOMETER DEX DIABETES CARE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA 120 HEMATOLOGY

FDA 510(k)

FDA Class 2 ·Hematology

8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAYER ADVIA 1650 CHEMISTRY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology