BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Rna Detection, Human Papillomavirus

    PMA: P120007 · Supplement: S030 · Decision Jun 2, 2023
    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
    S030
    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
    June 2, 2023
    Date Received
    March 28, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of manual post-cytology (cytology by ThinPrep Genesis Processor) aliquot, pre-cytology aliquot and post-cytology (cytology by ThinPrep Genesis Processor) aliquot removed by the ThinPrep Genesis Processor as acceptable samples for the Aptima HPV Assay and 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