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

    Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

    PMA: P110012 · Supplement: S002 · Decision Dec 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
    Trade Name
    VYSIS ALK BREAK APART FISH PROBE KIT
    PMA Number
    P110012
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    OWE
    Generic Name
    Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 26, 2012
    Date Received
    November 15, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEAD MIXING SYSTEM AND VALIDATE THE MIXING PROCESS IN THE MANUFACTURE OF THE HYBRIDIZATION BUFFER, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.

    Classifications

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

    Product Code Device Name
    OWE Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement