DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6

FDA 510(k)

FDA Class 2 ·Immunology

LANCER L-INA ANTI-C3

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer

FDA 510(k)

FDA Class 2 ·Immunology

SERAQUEST ANTI-SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST

FDA 510(k)

FDA Class 2 ·Immunology

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST

FDA 510(k)

FDA Class 2 ·Immunology

OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

ANA-SCREEN WITH MDSS

FDA 510(k)

FDA Class 2 ·Immunology

AUTOMATED IMMUNOPRECIPITIN METHOD/ICG

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)

FDA 510(k)

FDA Class 2 ·Immunology

STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH CENTROMERE

FDA 510(k)

FDA Class 2 ·Immunology

GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688

FDA 510(k)

FDA Class 2 ·Immunology

FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

GILFORD C4 COMPLEMENT REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER

FDA 510(k)

FDA Class 2 ·Immunology

The Optilite IgG3 kit

FDA 510(k)

FDA Class 2 ·Immunology