ACCESS LOW LEVEL IGE CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

ACCESS(R) TOTAL T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

KALLESTAD ROTAVIRUS MICROPLATE

FDA 510(k)

FDA Class 1 ·Microbiology

BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LIQUICHEK URINE CHEMISTRY CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIQUICHEK CARDIAC MARKER CONTROL LT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BIOPLEX 2200 TORC IGG

FDA 510(k)

FDA Class 2 ·Microbiology

ACCESS(R) THYROXINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EXPRESSO CARTRIDGE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY

FDA 510(k)

FDA Class 1 ·Microbiology

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