BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P990043 · Decision Feb 8, 2001
    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-EBK PLUS ASSAY
    PMA Number
    P990043
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    February 8, 2001
    Date Received
    July 2, 1999
    Expedited Review
    N
    Docket Number
    01M-0454

    Advisory Committee Statement

    APPROVAL FOR THE DIASORIN ETI-EBK PLUS ASSAY. THE DEVICE IS INDICATED FOR THE QUALITATIVE DETECTION OF HEPATITIS BE ANTIGEN (HBEAG) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-EBK PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT. THE DETECTION OF HBEAG IS INDICATIVE OF ACTIVE HBV REPLICATION, USUALLY CORRELATING WITH VIREMIA. A REACTIVE TEST IS PRESUMPTIVE LABORATORY EVIDENCE FOR INFECTION WITH HEPATITIS B VIRUS (HBV). FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE HBEAG ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.

    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)