BEUDAMED
    FDA PMA Approved (Withdrawn) 🇺🇸 United States

    PMA: P990042 · Decision Mar 30, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    DIASORIN ETI-AB-AUK PLUS ASSAY
    PMA Number
    P990042
    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    Approved (Withdrawn)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-0453

    Advisory Committee Statement

    APPROVAL FOR THE DIASORIN ETI-AB-AUK PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-AB-AUK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN ERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-AB-AUK PLUS IS INTENDED FOR MANUAL USE ONLY. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS FOR SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION. ANTI-HBS IS ALSO USED TO ASSESS LABORATORY DIAGNOSIS OF PAST EXPOSURE TO HEPATITIS B IN POTENTIAL HEPATITIS B VACCINE RECIPIENTS AND TO DETERMINE THE PRESENCE OS AN IMMUNE RESPONSE IN VACCINE RECIPIENTS. THE ANTI-HBS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HVB DISEASE OR THERAPY.