BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P230003 · Supplement: S005 · Decision Sep 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    Alinity m HR HPV Assay
    PMA Number
    P230003
    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
    September 5, 2024
    Date Received
    August 8, 2024
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to the request to include sample tube label requirements and edits to the the instrument Operations Manual Addendum.

    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