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

EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern

FDA 510(k)

FDA Class 2 ·Immunology

AUTOFLUOR V

FDA 510(k)

FDA Class 2 ·Immunology

HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA

FDA 510(k)

FDA Class 2 ·Immunology

CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

FDA 510(k)

FDA Class 2 ·Immunology

EU-TTG IGA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS

FDA 510(k)

FDA Class 2 ·Immunology