ACCESS FERRITIN ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS(R) TOTAL IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS VITAMIN B12 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS CORTISOL ASSAY (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

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