COMPLEXED PSA MICROTITER ELISA

FDA 510(k)

FDA Class 2 ·Immunology

OPUS PSA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

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

BAYER PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACTIVE PSA ELISA (DSL-10-9700)

FDA 510(k)

FDA Class 2 ·Immunology

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

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

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET

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

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS(R) HYBRITECH PSA ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE(R) THIRD GENERATION PSA

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

FDA Pre-Market Approval

FDA Class 2 ·BAYER IMMUNO 1 SYSTEM

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

FDA Pre-Market Approval

FDA Class 2 ·AIA-PACK PA PSA, ST AIA-PACK PA PSA

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

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE

TOTAL BILIRUBIN REAGENT, CONCENTRATED

FDA 510(k)

FDA Class 2 ·Clinical Chemistry