BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Urea Adult And Pediatric (Breath),

    PMA: P170022 · Supplement: S007 · Decision Feb 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Test, Urea Adult And Pediatric (Breath),
    Trade Name
    PyloPlus UBT System
    PMA Number
    P170022
    Supplement Number
    S007
    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 5, 2026
    Date Received
    August 5, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to add the PyloPlus UBT Auto Sampler used with glass breath collection tubes for use with the PyloPlus UBT System using the PyloPlus UBT Lab Analyzer (PPUBTLA -04), and for additions to test kit packaging.

    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),