BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Urea Adult And Pediatric (Breath),

    PMA: P100025 · Supplement: S007 · Decision Feb 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Test, Urea Adult And Pediatric (Breath),
    Trade Name
    BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)
    PMA Number
    P100025
    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 3, 2015
    Date Received
    August 8, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CAMBRIDGE ISOTOPE LABORATORIES, INC. (CIL'S) AMENDED DRUG MASTER FILE (DMF) #11378 ON BEHALF OF OAPI'S PMA APPLICATION WHICH USES THE DRUG AS A COMPONENT OF THE BREATHTEK UBT FOR H. PYLORI KIT. THIS SUPPLEMENT REQUESTS THE REVIEW OF THE FOLLOWING CHANGES TO THE DRUG MASTER FILE:1. PROCESS CHANGE TO MANUFACTURING SCALE TO ADD 18KG PROCESS;2. UPDATE TO SPECIFICATIONS AND TEST METHODS FOR 13C-UREA;3. CHANGES IN QC TESTING LOCATIONS; AND 4. CHANGES IN MANUFACTURING LOCATIONS FOR 18KG PROCESS.

    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),