BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P890064 · Supplement: S005 · Decision Aug 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    HYBRID CAPTURE(TM) SYSTEM HPV DNA ASSAY
    PMA Number
    P890064
    Supplement Number
    S005
    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
    August 15, 1997
    Date Received
    November 1, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for use of a cervical broom specimen collected and transported in the Cytyc Corporation PreservCyt(R) Solution for testing in the Digene Corporation Hybrid Capture(TM) System HPV DNA 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