BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P970037 · Supplement: S010 · Decision Jun 7, 2017
    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 System
    PMA Number
    P970037
    Supplement Number
    S010
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 7, 2017
    Date Received
    May 11, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changes being made in the hAFP antibody production: 1) use of additional L-glutamine supplement during the production of the coating antibody to the medium that contains nutrients (glucose and glutamine), and setting a recommended minimum concentration of glutamine during the production of the hAFP antibodies; and 2) addition of glutamine and glutamate testing of the routine anti-hAFP antibody production samples to the presently performed glucose and lactate testing.

    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