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

    PMA: P990044 · Supplement: S025 · Decision Jun 28, 2018
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    ETI-CORE-IGMK PLUS Assay
    PMA Number
    P990044
    Supplement Number
    S025
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 28, 2018
    Date Received
    May 30, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to testing of a reagent and contracting shipping logistics responsibilities of the finished kits to a qualified company.