BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gastric Emptying Breath Test (GEBT)

    Reg #: 3010031043 · FEI: 3009091796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CAIRN DIAGNOSTICS
    Registration Number
    3010031043
    FEI Number
    3009091796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    105 WESTPARK DR STE 150
    City
    Brentwood
    State
    TN
    ZIP
    37027
    Country
    US

    Regulatory Submissions

    PMA Number
    P110015

    Owner / Operator

    Firm Name
    Advanced Breath Diagnostics, LLC
    Operator Number
    10049228
    Address
    105 Westpark Drive, Suite 150
    City
    Brentwood
    State
    TN
    Postal Code
    37027
    Country
    US
    Correspondent
    Kerry Bush

    Products

    Device Name Product Code
    Gastric Emptying Breath Test PGE

    Proprietary Names

    Gastric Emptying Breath Test (GEBT) 13C-Spirulina 13C-Spirulina GEBT 13C-Spirulina Gastric Emptying Breath Test (GEBT)

    Establishment Types

    Manufacture Medical Device