BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Rna Detection, Human Papillomavirus

    PMA: P100042 · Supplement: S008 · Decision Sep 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Kit, Rna Detection, Human Papillomavirus
    Trade Name
    APTIMA HPV ASSAY
    PMA Number
    P100042
    Supplement Number
    S008
    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
    September 19, 2016
    Date Received
    August 28, 2015
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval of a new supplier for a critical raw material.

    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