BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P200017 · Decision Jul 14, 2021
    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
    ADVIA Centaur Anti-HBe2 (aHBe2) assay
    PMA Number
    P200017
    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 14, 2021
    Date Received
    March 9, 2020
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the ADIVA Centaur Anti-HBe2 (aHBe2) assay. The qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2–21 years old) and adult serum, EDTA plasma, or lithium heparin plasma using the ADVIA Centaur systems (XP/XPT/CP). Assay results, in conjunction with other laboratory results and clinical information may be used as an aid in the diagnosis of hepatitis B virus (HBV) infection in patients with signs or symptoms of hepatitis B infection, or with risk factors for HBV infection, or with known HBV infection. Results of the assay, in conjunction with other diagnostic information, may be used to aid in determining HBV seroconversion.

    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)