Alere i Instrument, Alere i Influenza A & B, Alere i Strep A

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G

FDA 510(k)

FDA Class 2 ·Immunology

DOCUMENT CARDIAC ASSAYED CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ID NOW COVID-19 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

CLEARVIEW EXACT II INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

INTROL CF PANEL I CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ(TM) ANTIBODY REAGENT SET II FOR IGM

FDA 510(k)

FDA Class 2 ·Immunology

DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MSC LIPID CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BINAXNOX STAPHYLOCOCCUS AUREUS TEST

FDA 510(k)

FDA Class 1 ·Microbiology

INTROL CF PANEL I CONTROL, MODEL: G106

FDA 510(k)

FDA Class 2 ·Microbiology

VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BILI-MIRROR MODEL BLM-1

FDA 510(k)

FDA Class 2 ·General Hospital

VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MICROTARGETING ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A

FDA 510(k)

FDA Class 2 ·Immunology