BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P990038 · Supplement: S005 · Decision Aug 20, 2003
    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
    DIASORIN ETI-MAK-2 PLUS ASSAY
    PMA Number
    P990038
    Supplement Number
    S005
    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
    Approved
    Decision Code
    APPR
    Decision Date
    August 20, 2003
    Date Received
    July 16, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A REVISION IN THE ASSAY PACKAGE INSERT THAT INCORPORATES A CHANGE IN THE INTERPRETATION ALGORITHM FOR REPEAT TESTING RESULTS THAT MAKE IT THE SAME AS THE INTERPRETATION FOR INITIAL TESTING. "THE USER SHOULD APPLY THE SAME INTERPRETATION OF RESULTS (I.E. REACTIVE SAMPLES SHOULD HAVE AN ABSORBANCE VALUE GREATER THAN 90% OF THE CUTOFF) WHEN INITIAL TESTING FOR SOME SAMPLES AND REPEAT TESTING FOR OTHER SAMPLES ARE PERFORMED ON THE SAME PLATE."

    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)