SERO/TEX CRP TEST

FDA 510(k)

FDA Class 2 ·Immunology

RANDOX MICROALBUMIN

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA SM ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

ST AIA-PACK CA 125 ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

FDA 510(k)

FDA Class 2 ·Immunology

AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-NRNP/SM ELISA (IGG)

FDA 510(k)

FDA Class 2 ·Immunology

NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

QM300 CONTROL F PACK

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896

FDA 510(k)

FDA Class 2 ·Immunology

TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Immunology

DISTAT ANTI-SCL-70 KIT

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE CCP3 IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO DIADEXUS PLAC TEST

FDA 510(k)

FDA Class 2 ·Immunology

TINA-QUANT APOLIPOPROTEIN VER.2

FDA 510(k)

FDA Class 2 ·Immunology

PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115

FDA 510(k)

FDA Class 2 ·Immunology

DIACROM *PLG

FDA 510(k)

FDA Class 1 ·Immunology

KALLESTEAD TOTAL IGE MICROPLATE KIT

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA RNP ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology