BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Rna Detection, Human Papillomavirus

    PMA: P120007 · Supplement: S025 · Decision Apr 27, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Kit, Rna Detection, Human Papillomavirus
    Trade Name
    Aptima HPV 16 18/45 Genotype Assay
    PMA Number
    P120007
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    OYB
    Generic Name
    Kit, rna detection, human papillomavirus
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 27, 2020
    Date Received
    November 1, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the use of ThinPrep 5000 post-processed samples on the Aptima HPV 16 18/45 Genotype assay.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OYB Kit, Rna Detection, Human Papillomavirus