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

    PMA: P050028 · Supplement: S007 · Decision Feb 4, 2010
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM
    PMA Number
    P050028
    Supplement Number
    S007
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 4, 2010
    Date Received
    January 8, 2010
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ELIMINATION OF IN-PROCESS CHEMICAL TESTING OF A BUFFER CONCENTRATE USED TO PREPARE THE MASTER MIX COMPONENT OF THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM.