LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

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

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

LIQUICHEK BNP CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LYPHOCHEK ASSAYED CHEMISTRY CONTROL

FDA 510(k)

FDA Class 1 ·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