BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P120014 · Supplement: S006 · Decision Apr 5, 2016
    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
    S006
    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
    April 5, 2016
    Date Received
    January 11, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change in the THxID-BRAF software to detect a specific fallback threshold value within the SDS file and in such case prevent the generation of a mutation report.

    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