AUTOSTAT II ANTI-JO-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

FDA 510(k)

FDA Class 2 ·Immunology

ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK

FDA 510(k)

FDA Class 2 ·Immunology

ST AIA-PACK AFP ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYSCA 15-3 II ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

UBI MAGIWEL(TM) ANA QUANTITATIVE

FDA 510(k)

FDA Class 2 ·Immunology

ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-DNA MICROASSAY

FDA 510(k)

FDA Class 2 ·Immunology

RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11

FDA 510(k)

FDA Class 2 ·Immunology

RAMP MYOGLOBIN ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

RHIGENE MESACUP-2 TEST RNP, MODEL M7741

FDA 510(k)

FDA Class 2 ·Immunology

Lp(a) Ultra

FDA 510(k)

FDA Class 2 ·Immunology

HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern

FDA 510(k)

FDA Class 2 ·Immunology

WAKO(TM) CRP

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA SCL-70 ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE ACA SCREEN (HRP)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls

FDA 510(k)

FDA Class 2 ·Immunology