BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P170005 · Supplement: S004 · Decision Apr 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit
    PMA Number
    P170005
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    OWD
    Generic Name
    Somatic gene mutation detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Medical Genetics
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 11, 2022
    Date Received
    March 10, 2022
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for addition of specifications to quality control testing.

    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