ROCHE DIAGNOSTICS ELECSYS AFP CALSET II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k)

FDA Class 2 ·Immunology

AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

FDA 510(k)

FDA Class 2 ·Immunology

AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP (LIST 7A48)

UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION

FDA 510(k)

FDA Class 2 ·Immunology

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT ARCHITECHT AFP

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ENCORE AFP

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·AFP CONTROL PACK

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP

ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211

FDA 510(k)

FDA Class 2 ·Immunology

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·MENICON SF-P (TM)

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX AFP ASSAY

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R)-E AFP

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R)-E AFP