BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Urea Adult And Pediatric (Breath),

    PMA: P170022 · Supplement: S001 · Decision Nov 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Test, Urea Adult And Pediatric (Breath),
    Trade Name
    PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer
    PMA Number
    P170022
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    OZA
    Generic Name
    Test, urea adult and pediatric (breath),
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 30, 2022
    Date Received
    May 4, 2022
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer and is indicated for The PyloPlus UBT system. The device, as modified, is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis of H. pylori infection in adults 18 years old and older. The PyloPlus UBT system consists of the PyloPlus UBT Kit and the PyloPlus UBT analyzer. The analyzer is an infrared Spectrometer used for the measurement of the ratio of 13CO2 to 12CO2 in breath samples. The PyloPlus UBT system is for use by trained health care professionals as prescribed by a physician.

    Classifications

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

    Product Code Device Name
    OZA Test, Urea Adult And Pediatric (Breath),