BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Tumor Marker, For Detection Of Bladder Cancer

    PMA: P940035 · Supplement: S017 · Decision Jul 12, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    System, Test, Tumor Marker, For Detection Of Bladder Cancer
    Trade Name
    NMP22 BladderChek Test
    PMA Number
    P940035
    Supplement Number
    S017
    Device Class
    FDA Class 3
    Product Code
    NAH
    Generic Name
    System, test, tumor marker, for detection of bladder cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 12, 2022
    Date Received
    February 8, 2022
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to manufacture Alere NMP22 BladderChek Test under Abbott Diagnostics Scarborough, Inc.s new brand name: NMP22 BladderChek Test.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NAH System, Test, Tumor Marker, For Detection Of Bladder Cancer