BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P050028 · Supplement: S077 · Decision Aug 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    cobas AmpliPrep/cobas TaqMan HBV Test, v2
    PMA Number
    P050028
    Supplement Number
    S077
    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
    August 13, 2019
    Date Received
    July 15, 2019
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of an instruction to the labeling to visually inspect reagent cassette and vial prior to use.

    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