ACCESS HTSH ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY

FDA 510(k)

FDA Class 1 ·Microbiology

LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

KALLESTEAD TOTAL IGE MICROPLATE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS CK-MB REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS(R) CORTISOL REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS(R) FREE T4 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS FREE T3 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIQUICHEK URINE CHEMISTRY CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI

FDA 510(k)

FDA Class 2 ·Immunology

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

LIQUICHEK BNP CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LYPHOCHEK ASSAYED CHEMISTRY CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

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