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

    PMA: P050028 · Supplement: S012 · Decision Dec 7, 2010
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0
    PMA Number
    P050028
    Supplement Number
    S012
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 7, 2010
    Date Received
    November 8, 2010
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CLEAN IN PLACE CYCLE CHANGES AND MINOR EQUIPMENT MODIFICATIONS FOR THE TWO LARGE SCALE BULK FORMULATION (LSBF) 10,000 L TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINE WITHIN THE FDA APPROVED PCR MANUFACTURING CENTER FACILITY IN BRANCHBURG, NEW JERSEY.