BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P890064 · Supplement: S021 · Decision Mar 31, 2010
    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 (HC2) HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
    PMA Number
    P890064
    Supplement Number
    S021
    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
    March 31, 2010
    Date Received
    February 3, 2010
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A TRADE NAME CHANGE FOR THE HYBRID CAPTURE 2 (HC2) HIGH-RISKHPV DNA TEST AND HYBRID CAPTURE 2 (HC2) HPV DNA TEST. THE DEVICES, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST ANDDIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST AND ARE INDICATED FOR THE QUALITATIVE DETECTIONOF SPECIFIED TYPES OF HUMAN PAPILLOMAVIRUS (HPV) DNA IN CERVICAL SPECIMENS.

    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