BINAX LEGIONELLA URINARY ANTIGEN EIA

FDA 510(k)

FDA Class 2 ·Microbiology

VENTRESCREEN, HCG URINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICRO TARGETING DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICROTABLE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICROTARGETING XL STAR DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

FETALTROL

FDA 510(k)

FDA Class 2 ·Hematology

VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

GAS, CALIBRATION, SPECIFIED CONCENTRATION

FDA 510(k)

FDA Class 1 ·Anesthesiology

BinaxNOW G6PD Test

FDA 510(k)

FDA Class 2 ·Hematology

SPQ(TM) ANTIBODY REAGENT SET II FOR C3

FDA 510(k)

FDA Class 1 ·Immunology

DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BINAX L.S. TSH IRMA TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHOLESTEROL CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SPECIFIC IGE EIA-TURBO ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

HYPERFREE

FDA 510(k)

FDA Class 1 ·Anesthesiology

BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI

FDA 510(k)

FDA Class 1 ·Microbiology