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

    PMA: P050028 · Supplement: S002 · Decision Nov 25, 2008
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    COBAS TAQMAN HBV TEST
    PMA Number
    P050028
    Supplement Number
    S002
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 25, 2008
    Date Received
    October 31, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USE DIN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USE IN THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM WITH THE ACTIVATOR 4,5 DICYANOIMIDAZOLE (DCI).