System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ST AIA-PACK PA

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ENZYMUN-TEST{R} AFP

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)

FDA 510(k)

FDA Class 2 ·Immunology

DELFIA(TM) FERRITIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

VITROS Immunodiagnostic Products CEA Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

FDA 510(k)

FDA Class 2 ·Immunology

AURAFLEX B2-MICROGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307

FDA 510(k)

FDA Class 2 ·Immunology

CAPILLARYS URINE

FDA 510(k)

FDA Class 2 ·Immunology

ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805

FDA 510(k)

FDA Class 2 ·Immunology

HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology