Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS RUBELLA IGG

FDA 510(k)

FDA Class 2 ·Microbiology

ACCESS PROLACTIN ASSAY (MODIFICATION)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

ACCESS SPECIFIC IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS ULTRASENSITIVE INSULIN ASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0

FDA 510(k)

FDA Class 2 ·Hematology

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 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