DOCUMENT REFLECTANCE II LINEARITY TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.

FDA 510(k)

FDA Class 2 ·Immunology

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

LISTENAIDER II

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROEPG SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BASELINE CALIBRATION VERIFICATION CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

VENTRESIGN STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology

BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

FDA 510(k)

FDA Class 2 ·Microbiology

FLIPSCREEN QAT

FDA 510(k)

FDA Class 2 ·Immunology

EQUATE(TM) AQR APO AL/B DUO CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

FDA 510(k)

FDA Class 2 ·Microbiology

VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BINAX EQUATE GLYCOHEMOGLOBIN

FDA 510(k)

FDA Class 2 ·Hematology

BinaxNOW™ COVID-19 Antigen Self Test; BinaxNOW™ COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

MICROCO

FDA 510(k)

FDA Class 2 ·Anesthesiology

VENTRESCREEN HCG URINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALERE PBP2A TEST

FDA 510(k)

FDA Class 2 ·Microbiology