BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P160037 · Supplement: S002 · Decision May 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    Onclarity HPV Assay
    PMA Number
    P160037
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MAQ
    Generic Name
    KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 13, 2019
    Date Received
    February 26, 2019
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for use of a modified SurePath vial for collection of specimens to be tested with the Onclarity HPV Assay, and the automated transfer of pre- and post- cytology aliquots using the BD Totalys Multiprocessor for testing with the BD Onclarity Assay.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAQ Kit, Dna Detection, Human Papillomavirus