BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P050028 · Supplement: S017 · Decision Jul 7, 2011
    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 V2.0
    PMA Number
    P050028
    Supplement Number
    S017
    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 7, 2011
    Date Received
    March 8, 2011
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO IN-PROCESS TESTING PROCEDURES FOR THE ELUTION BUFFER AND MANGANESE REAGENT TO BE IMPLEMENTED AT THE MANUFACTURING SITE IN SOMERVILLE, NEW JERSEY.

    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