BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010052 · Decision Jul 22, 2002
    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
    IMMULITE 2000 XPI ANTI-HBS
    PMA Number
    P010052
    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
    July 22, 2002
    Date Received
    August 31, 2001
    Expedited Review
    N
    Docket Number
    03M-0287

    Advisory Committee Statement

    APPROVAL FOR THE IMMULITE ANTI-HBS AND IMMULITE 2000 ANTI-HBS. THE DEVICES ARE INDICATED FOR: IMMULITE ANTI-HBS: FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED OR EDTA). ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION. IMMULITE 2000 ANTI-HBS: FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN SERUM AND PLASMA (HEPARINIZED OR EDTA). ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION, OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION.

    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)