BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Urea Adult And Pediatric (Breath),

    PMA: P100025 · Supplement: S008 · Decision Mar 5, 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
    PMA Number
    P100025
    Supplement Number
    S008
    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
    March 5, 2015
    Date Received
    January 13, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN AMENDMENT TO THE DRUG MASTER FILE FOR THE FOLLOWING CHANGES: 1) ADDITIONAL PROCESS DEVELOPMENT WORK FOR THE PURIFICATION PROCESS; 2) VALIDATION OF THE PURIFICATION PROCESS IMPROVEMENTS;3) SITE TRANSFER FOR THE PURIFICATION PROCESS; 4) CHANGE TO A SPECIFICATION OF A STARTING MATERIAL; 5. ADDITIONAL SIZES FOR THE OUTER CONTAINER AND INNER BAGS FOR THE PURIFICATION PROCESS; AND 6) UPDATED STABILITY INFORMATION.

    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),