ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

TPSA FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

FDA 510(k)

FDA Class 2 ·Immunology

LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG

FDA 510(k)

FDA Class 2 ·Microbiology

MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

HERPESELECT 2 ELISA IGG, MODEL ELO920G

FDA 510(k)

FDA Class 2 ·Microbiology

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls

FDA 510(k)

FDA Class 2 ·Microbiology

PROSTATE SPECIFIC ANTIGEN METHOD

FDA 510(k)

FDA Class 2 ·Immunology

COMPLEXED PSA MICROTITER ELISA

FDA 510(k)

FDA Class 2 ·Immunology

OPUS PSA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV

FDA 510(k)

FDA Class 2 ·Microbiology

ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

FDA 510(k)

FDA Class 2 ·Immunology

TOTAL PSA MICROTITER ELISA

FDA 510(k)

FDA Class 2 ·Immunology

SeraQuest HSV Type 2 Specific IgG

FDA 510(k)

FDA Class 2 ·Microbiology

PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G

FDA 510(k)

FDA Class 2 ·Microbiology

SeraQuest Herpes Type 1 Specific IgG

FDA 510(k)

FDA Class 2 ·Microbiology

BAYER PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology