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

    PMA: P050028 · Supplement: S016 · Decision Mar 22, 2011
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0
    PMA Number
    P050028
    Supplement Number
    S016
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 22, 2011
    Date Received
    March 1, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    DISCONTINUATION OF FINAL BULK TESTING REQUIREMENTS FOR BULK QUANTITATION STANDARD (QS) AND INTERNAL CONTROL (IC) REAGENTS FOR 17 QS/IC PRODUCTS USED WITH THE ASSOCIATED ASSAYS.