ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Phadia Prime

FDA 510(k)

FDA Class 2 ·Immunology

BINDAZYME ANTIGLIADIN IGG

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT

FDA 510(k)

FDA Class 2 ·Immunology

PHADEBAS RAST ALLERGEN DISCS

FDA 510(k)

FDA Class 2 ·Immunology

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

TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT

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

ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology