BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P080026 · Supplement: S006 · Decision Oct 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    HBV ASSAY
    PMA Number
    P080026
    Supplement Number
    S006
    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
    October 15, 2013
    Date Received
    February 15, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) THE ADDITION OF AN OPTIONAL EXTENDED USE FEATURE TO ALLOW PREPARED AMPLIFICATION MASTER MIX AND INTERNAL CONTROL TO BE USED SECOND TIME WITHIN 14 DAYS OF INITIAL USE IF STORED AT 2°C TO 8°C; 2) IMPROVEMENTS TO THE PREPARATION AND PROCESSING STEPS OF THE AMPLIFICATION MASTER MIX BY THE ABBOTT M2000SP INSTRUMENT; AND 3) ASSOCIATED SOFTWARE REVISIONS.

    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