BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P130015 · Supplement: S017 · Decision Apr 18, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Elecsys HBeAg Test System
    PMA Number
    P130015
    Supplement Number
    S017
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 18, 2023
    Date Received
    September 30, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the migration of the Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg to the cobas e 402 immunoassay analyzer