BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Urea Adult And Pediatric (Breath),

    PMA: P170022 · Supplement: S005 · Decision Feb 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Test, Urea Adult And Pediatric (Breath),
    Trade Name
    PyloPlus UBT System
    PMA Number
    P170022
    Supplement Number
    S005
    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
    February 12, 2025
    Date Received
    October 25, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the PyloPlus UBT system used with the PyloPlus UBT Hp Pro Analyzer with improved connectivity, user interface, and extended function testing as a standalone device without a PC.

    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),