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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

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

    PMA: P990038 · Decision Mar 30, 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 MAK-2 PLUS ASSAY
    PMA Number
    P990038
    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    Approved (Withdrawn)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
    March 30, 2001
    Date Received
    July 2, 1999
    Expedited Review
    N
    Docket Number
    01M-0451

    Advisory Committee Statement

    APPROVAL FOR THE DIASORIN ETI-MAK-2 PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-MAK-2 PLUS IS AN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-MAK-2 PLUS IS INTENDED FOR MANUAL USE AND WITH THE BIOCHEM IMMUNOSYSTEMS LABOTECH/ETI-LAB AUTOMATED INSTRUMENT. THE DETECTION OF HBSAG IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR HEPATITIS B VIRUS (HBV) INFECTION, EITHER ACUTE OR CHRONIC. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ETI-MAK-2 PLUS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. THIS ASSAY HAS NOT BEEN FDA-APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.

    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)