BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Kit, Test,Alpha-Fetoprotein For Testicular Cancer

    PMA: P820060 · Supplement: S011 · Decision May 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Kit, Test,Alpha-Fetoprotein For Testicular Cancer
    Trade Name
    ABBOTT AXSYM AFP
    PMA Number
    P820060
    Supplement Number
    S011
    Device Class
    FDA Class 2
    Product Code
    LOJ
    Generic Name
    KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 16, 1997
    Date Received
    April 21, 1997
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A SYSTEM PERFORMED AUTOMATED DILUTION PROTOCOL FOR A 1:101 SAMPLE DILUTION OF AMNIOTIC FLUID AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1)HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOUS TESTICULAR CANCER. (2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION OT AID INT HE DETECTION OF FETAL OPEN NEURAL TUBE DETECTS (NTD). TEST RESULTS WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY OR AMNIOGRAPHY ARE A SAFE AND EFFECTIVE AID IN THE DETECTION OF FETAL OPEN NTD.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer