BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P090028 · Decision May 11, 2011
    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
    VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
    PMA Number
    P090028
    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
    May 11, 2011
    Date Received
    December 16, 2009
    Expedited Review
    N
    Docket Number
    11M-0348

    Advisory Committee Statement

    APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK, CALIBRATOR AND CONTROLS. THIS DEVICE IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEM. TEST RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B, OR RECOVERY FROM HEPATITIS B INFECTION. VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG CALIBRATOR FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION. VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG CONTROLS - FOR USE IN MONITORING THE PERFORMANCE OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS WHEN USED FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION WHEN USING THE VITROS IMMUNODIAGNOSTIC PRODUCTS HBE-AG REAGENT PACK.

    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)