ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-DSDNA ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

K-ASSAY C4

FDA 510(k)

FDA Class 2 ·Immunology

TURBIQUANT MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

A1AT Genotyping Test

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT CA 19-9XR ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS OV MONITOR ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

MESACUP TEST MPO, MODEL 11053

FDA 510(k)

FDA Class 2 ·Immunology

TINA-QUANT TRANSFERRIN VER.2

FDA 510(k)

FDA Class 2 ·Immunology

IMMULISA PR3 ANTIBODY ELISA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

FDA 510(k)

FDA Class 2 ·Immunology

TINA-QUANT COMPLEMENT C4 TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

RADIAS ANA SCREEN ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN Anti-BP230-CF ELISA (IgG)

FDA 510(k)

FDA Class 2 ·Immunology

PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT

FDA 510(k)

FDA Class 1 ·Immunology

SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology