BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P970037 · Decision Mar 31, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
    Trade Name
    AUTODELFIA HAFP TEST KIT
    PMA Number
    P970037
    Device Class
    FDA Class 3
    Product Code
    LOK
    Generic Name
    KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 31, 1998
    Date Received
    August 26, 1997
    Expedited Review
    N
    Docket Number
    98M-0306

    Advisory Committee Statement

    The device is intended for the quantitative determination of human alpha-fetoprotein (AFP) in maternal serum and amniotic fluid obtained between the 15th and 21st weeks of gestation. The assay is to be peformed on the 1235 AutoDELFIA(TM) automatic immunoassay system, and is intended for use only in conjunction with other diagnostic tools such as ultrasound and amniography as an aid in the detection of Open Neural Tube Defects (ONTDs).

    Classifications

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

    Product Code Device Name
    LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects