BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P010053 · Supplement: S015 · Decision Aug 30, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    IMMULITE® 2000 Anti-HBc IgM
    PMA Number
    P010053
    Supplement Number
    S015
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 30, 2023
    Date Received
    March 21, 2022
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the change in labeling to include a limitation regarding interference from the drug STRENSIQ.