AMIZYME-ANA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

HEMAGEN ENA SM/RMP KIT (EIA METHOD)

FDA 510(k)

FDA Class 2 ·Immunology

OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN

FDA 510(k)

FDA Class 2 ·Immunology

DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ENA-4 PROFILE ELISA

FDA 510(k)

FDA Class 2 ·Immunology

HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

Buhlmann fCAL turbo and CALEX Cap

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-GLIADIN IGA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus

FDA 510(k)

FDA Class 2 ·Immunology

IL TEST CALIBRATION SET APO A1B

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227

FDA 510(k)

FDA Class 2 ·Immunology

MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET

FDA 510(k)

FDA Class 2 ·Immunology

SYNELISA CENP-B ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

QUICKVUE ONE-STEP ALLERGEN SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

ALLERCOAT MULTISCREEN DISCS

FDA 510(k)

FDA Class 2 ·Immunology

UNICAP GLIADIN IGA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ImmuLisa Enhanced RNA POL III Antibody ELISA

FDA 510(k)

FDA Class 2 ·Immunology

K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Immunology