BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P930036 · Supplement: S001 · Decision Jul 15, 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
    ACS: CENTAUR AFP IMMUNOASSAY
    PMA Number
    P930036
    Supplement Number
    S001
    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
    July 15, 1998
    Date Received
    May 1, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to add the existing AFP assay performed on the ACS:180 to a new generation of instrumentation, the Centaur and is indicated for the quantitative determination of alpha-fetoprotein (AFP) in the following:human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, as an aid in detecting open neura tube defects (NTDs) when used in conjucntion with ultrasonography and amniography testing, using the Chiron Diagnostics ACS:Centaur(TM) Automated Chemiluminescence System.

    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