HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BIOPLEX 2200 EBV IGG AND SYPHILIS IGG

FDA 510(k)

FDA Class 2 ·Microbiology

ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VARIANT II HEMOGLOBIN A1C

FDA 510(k)

FDA Class 2 ·Hematology

ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

KALLESTAD RSV MICROPLATE EIA

FDA 510(k)

FDA Class 1 ·Microbiology

ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

ACCESS CHLAMYDIA ASSAY

FDA 510(k)

FDA Class 1 ·Microbiology

ACCESS MYOGLOBIN REAGENTS

FDA 510(k)

FDA Class 2 ·Immunology

LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACCESS ALLERGEN DOG EPITHELIM

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS TOTAL BHCG ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK

FDA 510(k)

FDA Class 2 ·Hematology

KALESTAD ANA MICROPLATE EIA

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS TOTAL T3 ASSAY (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS VITAMIN B12 ASSAY (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VARIANT II TURBO HbA1c Kit - 2.0

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

D-10 Hemoglobin A1c Program

FDA 510(k)

FDA Class 2 ·Clinical Chemistry