BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Kit, Rna Detection, Human Papillomavirus

    PMA: P120007 · Supplement: S033 · Decision Oct 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Kit, Rna Detection, Human Papillomavirus
    Trade Name
    Aptima HPV 16 18/45 Genotype Assay (Box 1); Aptima HPV 16 18/45 Genotype Assay (Box 2); Aptima HPV 16 18/45 Genotype Ass
    PMA Number
    P120007
    Supplement Number
    S033
    Device Class
    FDA Class 3
    Product Code
    OYB
    Generic Name
    Kit, rna detection, human papillomavirus
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 7, 2025
    Date Received
    September 25, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to adjust raw material test method

    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