SPQ TM TEST SYSTEM II FOR CRP

FDA 510(k)

FDA Class 2 ·Immunology

HBM HEMOGLOBINOMETER

FDA 510(k)

FDA Class 2 ·Hematology

FilmArray Pneumonia/Pneumoniaplus Control

FDA 510(k)

FDA Class 2 ·Microbiology

VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

BINAX STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology

FINETONE FSC,

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

TURBO-RAST SPECIFIC IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR COMPLEMENT C3

FDA 510(k)

FDA Class 2 ·Immunology

BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ(TM) ANTIBODY REAGENT SET II FOR TRF

FDA 510(k)

FDA Class 2 ·Immunology

VALIDATE D-Dimer Calibration Verification/Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

CLEARVIEW ADVANCED STREP A , MODEL 737-430

FDA 510(k)

FDA Class 1 ·Microbiology

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SteriZign Signatur Device Protection System

FDA 510(k)

FDA Class 2 ·General Hospital

BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST

FDA 510(k)

FDA Class 1 ·Microbiology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader

FDA 510(k)

FDA Class 2 ·Microbiology

DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD

FDA 510(k)

FDA Class 1 ·Clinical Chemistry