BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P180039 · Decision Feb 21, 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-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
    PMA Number
    P180039
    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
    February 21, 2020
    Date Received
    September 26, 2018
    Expedited Review
    N
    Docket Number
    20M-0984

    Advisory Committee Statement

    Approval for the LIAISON XL MUREX Anti-HBs. The device is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative and quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) in human adult and pediatric (2 – 21 years) serum and plasma (lithium and sodium heparin and K2 EDTA) including separator tubes, on the LIAISON XL Analyzer. Assay results in conjunction with other hepatitis B virus (HBV) serological markers and clinical information may be used as an aid in the diagnosis of HBV infection in patients with symptoms of hepatitis or who may be at risk for HBV infection. The assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. The assay is not approved for use in screening blood, plasma or tissue donors. The LIAISON XL MUREX Control Anti-HBs (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON XL MUREX Anti-HBs assay. The performance characteristics of LIAISON XL MUREX Control Anti-HBs have not been established for any other assays or instrument platforms.The LIAISON XL MUREX Anti-HBs Verifiers (level 1, 2, 3, and level 4) are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON XL MUREX Anti-HBs assay. The performance characteristics of LIAISON XL MUREX Anti-HBs Verifiers have not been established in connection with any other assay or instrument platforms.

    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)