BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P180049 · Decision Aug 29, 2020
    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
    LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe
    PMA Number
    P180049
    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
    August 29, 2020
    Date Received
    December 19, 2018
    Expedited Review
    N
    Docket Number
    20M-1822

    Advisory Committee Statement

    Approval for the LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe. The LIAISON® XL MUREX Anti-HBe assay is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative detection of total antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years) serum and plasma (lithium and sodium heparin, sodium citrate and K2 EDTA), including separator tubes, on the LIAISON® XL Analyzer. 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 symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection.This assay is not approved for use in screening blood, plasma or tissue donors. The LIAISON® XL MUREX Control Anti-HBe (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL MUREX Anti-HBe assay. The performance characteristics of LIAISON® XL MUREX Control Anti-HBe have not been established for any other assays or instrument platforms different from LIAISON® XL Analyzer.

    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)