FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

AUTOANTIBODY REAGENTS, AFT SYSTEM II

FDA 510(k)

FDA Class 2 ·Immunology

KALLESTAD QUANTITOPE LOW LEVEL IGE REAG

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-RETICULIN ANTIBODY (ARA) TEST

FDA 510(k)

FDA Class 2 ·Immunology

IBD-CHEK

FDA 510(k)

FDA Class 1 ·Immunology

Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-JO-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE IGG GLIADIN ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Idylla MSI Test

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA CENTAUR CA 19-9 ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

QM300 IGG ANTIBODY PACK

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

SERATEST ENA(RNP/SM) DETERMINATION

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNEX CRP

FDA 510(k)

FDA Class 2 ·Immunology

ELISA-DOXA SM

FDA 510(k)

FDA Class 2 ·Immunology

ABBOTT MATRIX AERO PLUS SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A

FDA 510(k)

FDA Class 2 ·Immunology