BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT

FDA 510(k)

FDA Class 2 ·Microbiology

BIOPLEX VASCULITIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

BIOPLEX 2200 EBV IGM KIT

FDA 510(k)

FDA Class 1 ·Microbiology

ANA-SCREEN WITH MDSS

FDA 510(k)

FDA Class 2 ·Immunology

BIOPLEX 2200 APLS IGM

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

MULTI-ANALYTE DETECTION SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PLATELIA TOXO IGM KIT MODEL 26211

FDA 510(k)

FDA Class 2 ·Microbiology

LYPHOCHEK DIABETES CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

Liquichek Maternal Serum II Control

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIQUICHEK OPIATE CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

LIQUID ASSAYED MULTIQUAL PREMIUM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL

FDA 510(k)

FDA Class 2 ·Microbiology

LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIQUICHEK TUMOR MARKER CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry