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

    PMA: P180049 · Supplement: S011 · Decision Dec 8, 2022
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe
    PMA Number
    P180049
    Supplement Number
    S011
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 8, 2022
    Date Received
    November 10, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Elimination of a manufacturing step for kit component.