BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    PMA: P990038 · Supplement: S019 · Decision Jan 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
    Trade Name
    ETI-MAK-2 PLUS ASSAY
    PMA Number
    P990038
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    LOM
    Generic Name
    Test, hepatitis b (b core, be antigen, be antibody, b core igm)
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 10, 2014
    Date Received
    December 27, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MINOR LABELING CHANGE AND CHANGES IN LOCATION FROM ONE ROOM TO ANOTHER ROOM WITHIN THE SAME BUILDING FOR THE MANUFACTURING ACTIVITIES OF MANUAL KIT PACKAGING, SAMPLING OF INCOMING HUMAN SERUM/PLASMA UNITS, AND HEAT INACTIVATION OF HBSAG POSITIVE SAMPLES.

    Classifications

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

    Product Code Device Name
    LOM Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)