BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P180043 · Supplement: S010 · Decision May 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    QIAGEN therascreen® FGFR RGQ RT-PCR Kit
    PMA Number
    P180043
    Supplement Number
    S010
    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
    May 6, 2026
    Date Received
    February 17, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a minor material change which would replace the BSA (Bovine Serum Album) in the PCR Master Mix tubes with a recombinant Human Serum Albumin (rHSA).

    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