BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P100020 · Supplement: S004 · Decision Jun 25, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    ROCHE COBAS HPV TEST
    PMA Number
    P100020
    Supplement Number
    S004
    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
    June 25, 2013
    Date Received
    April 2, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR PROCESSING OF RESIDUAL CERVICAL SAMPLE DIRECTLY FROM THE PRESERVCYT¿ VIAL (HOLOGIC, INC., BEDFORD, MA) AFTER PROCESSING FOR LIQUID-BASED CYTOLOGY (LBC) USING EITHER THE HOLOGIC THINPREP® 2000 OR THINPREP® 3000 PROCESSORS AND TESTING ON THE COBAS® 4800 SYSTEM DIRECTLY FROM THE PRESERVCYT VIAL (PRIMARY VIAL). APPROVAL FOR CAPABILITY TOADD OPTIONAL NON-IVD SOFTWARE TO THE COBAS® 4800 SYSTEM THAT IS USED TO PERFORM THE COBAS® HPV TEST WAS ALSO REQUESTED.

    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