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

    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

    PMA: P030052 · Supplement: S007 · Decision Jun 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
    Trade Name
    UROVYSION BLADDER CANCER KIT ASSAY
    PMA Number
    P030052
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    NSD
    Generic Name
    Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 1, 2011
    Date Received
    May 6, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF PROCESS CHANGE TO THE MANUFACTURE OF THE FISH DNA BULK PROBE SOLUTION, INCLUDING A NEW FISH DNA EXTRACTION PROCESS, A NEW SONICATION EQUIPMENT, A NEW AMINATION/LABELING PROCEDURE, AND A SUPPLEMENTAL DNA PURIFICATION PROCESSING STEP TO REDUCE RNA CARRY-OVER.

    Classifications

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

    Product Code Device Name
    NSD Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence