BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P890064 · Supplement: S014 · Decision May 4, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST
    PMA Number
    P890064
    Supplement Number
    S014
    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 4, 2004
    Date Received
    November 5, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO INCLUDE THE OPTIONAL USE OF AN AUTOMATED, HIGH-THROUGHPUT ROBOTIC PIPETTING AND MICROPLATE HANDLING SYSTEM KNOWN AS THE DIGENE RAPID CAPTURE SYSTEM (RCS).

    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