BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P200013 · Supplement: S015 · Decision Jul 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    Alinity m HBV
    PMA Number
    P200013
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    MKT
    Generic Name
    Hepatitis Viral B DNA Detection
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 18, 2023
    Date Received
    May 1, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change of the Alinity m HBV Assay to implement a new application specification file containing an improved PCR reagent assembly process that mitigates the potential for overflow at the Alinity m Amplification (AMP) Tray, thus minimizing the potential risk for carryover. The Alinity m HBV Kit package insert is also being updated to reflect the carryover rate using the new application specification file.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKT Hepatitis Viral B Dna Detection