BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P120014 · Supplement: S002 · Decision Dec 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    THXID BRAF KIT
    PMA Number
    P120014
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    OWD
    Generic Name
    Somatic gene mutation detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 22, 2014
    Date Received
    October 15, 2014
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING SEVEN CHANGES: CLEANING OF DRIPPING AND SPHERES FILLING EQUIPMENT, TRANSFER OF QUALITY CONTROL ACTIVITIES INTO ANOTHER ROOM, RAW MATERIAL CHANGES FOR BOTTLES AND CAPS FOR THXID-BRAF PUR, MODIFICATION OF A FUNCTIONAL QUALITY CONTROL (QC) TEST FOR THE THXIDTM-BRAF PUR KIT, TRANSFER OF BUFFER MANUFACTURING (FOR THE BRAF PURIFICATION KIT) INTO A NEW BUILDING AT QIAGEN, CHANGES IN DNASE REFERENCE (AM2224) USED IN THE DETERMINATION OF DNASE ACTIVITY IN WATER AND REAGENTS, AND SHELF LIFE EXTENSION FOR RNA TRANSCRIPTS AND PLASMIDS.

    Classifications

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

    Product Code Device Name
    OWD Somatic Gene Mutation Detection System