BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Urea Adult And Pediatric (Breath),

    PMA: P100025 · Supplement: S009 · Decision Nov 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Test, Urea Adult And Pediatric (Breath),
    Trade Name
    BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
    PMA Number
    P100025
    Supplement Number
    S009
    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 23, 2015
    Date Received
    July 16, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR (1) A NEW REGULATORY ANALYTICAL REFERENCE METHOD FOR ANALYSIS OF THE FINAL DRUG PRODUCT, PRANACTIN-CITRIC, THE DRUG COMPONENT OF THE BREATHTEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT); AND (2) THE ADDITION OF AAIPHARMA SERVICES CORPORATION (AAIPHARMA) IN WILMINGTON, NORTH CAROLINA (FEI NUMBER 1049418) AS A SECOND ANALYTICAL TESTING FACILITY FOR PRANACTIN-CITRIC.

    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),