VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

BIO-RAD VARIANT NBS SICKLE CELL PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology

BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200

FDA 510(k)

FDA Class 2 ·Immunology

BIO-RAD D-10 DUAL PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology

VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS PROGESTERONE ASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACCESS CORTISOL REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

D-10 HEMOGLOBIN A1C

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS TOTAL BHCG ASSAY (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MONOLISA ANTI-HAV EIA

FDA 510(k)

FDA Class 2 ·Microbiology

ACCESS DIGOXIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

D-100 HbA1c, D-100 HbA1c Calibrator Pack

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS THYROID UPTAKE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET

FDA 510(k)

FDA Class 2 ·Microbiology

VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MONOLISA ANTI-HAV IGM EIA

FDA 510(k)

FDA Class 2 ·Microbiology

Bio-Rad

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