LISTENAIDER II

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROEPG SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

BASELINE CALIBRATION VERIFICATION CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

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

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

SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN

FDA 510(k)

FDA Class 2 ·Immunology

VENTREX COATED TUBE T3 UPTAKE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ID NOW Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray BCID2 Control Panel M416

FDA 510(k)

FDA Class 2 ·Microbiology

microTargeting Guideline 4000 5.0 System

FDA 510(k)

FDA Class 2 ·Neurology

BINAX IRMA TOTAL BETA-HCG TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry