IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA SM ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

TEST, (IVDP) SMOOTHMUSCLE ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERUM TO HUMAN C-REACTIVE PROTEINS

FDA 510(k)

FDA Class 2 ·Immunology

BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

IMX FERRITIN

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

Maverick RNP Assay and Maverick Diagnostic System

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

FDA 510(k)

FDA Class 2 ·Immunology

CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

PHARMACIA CAP SYSTEM PHADIATOP FEIA

FDA 510(k)

FDA Class 2 ·Immunology

SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

IGM RHEUMATOID FACTOR TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267

FDA 510(k)

FDA Class 2 ·Immunology

MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING

FDA 510(k)

FDA Class 2 ·Immunology

QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT

FDA 510(k)

FDA Class 2 ·Immunology

READS(R) IGA ANTI-CARDIOLIPIN TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR COMPLEMENT C4

FDA 510(k)

FDA Class 2 ·Immunology