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

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

FDA 510(k)

FDA Class 2 ·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

ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

ACCESS MYOGLOBIN REAGENTS

FDA 510(k)

FDA Class 2 ·Immunology

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

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