BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P150014 · Supplement: S056 · Decision Oct 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    cobas® HBV
    PMA Number
    P150014
    Supplement Number
    S056
    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
    July 8, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for cobas HBV on the upgraded cobas 6800/8800 Systems 2.0

    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