BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P200013 · Supplement: S027 · Decision Oct 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    Alinity m HBV
    PMA Number
    P200013
    Supplement Number
    S027
    Device Class
    FDA Class 2
    Product Code
    MKT
    Generic Name
    Hepatitis Viral B DNA Detection
    Regulation Number
    866.3174
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 17, 2025
    Date Received
    September 5, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to release software Alinity m System Software version 1.9.1., which incorporates all changes, in the US for a mandatory customer software update.

    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