BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BreathTek

    Reg #: 1524213 · FEI: 1524213 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MERIDIAN BIOSCIENCE, INC.
    Registration Number
    1524213
    FEI Number
    1524213
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3471 River Hills Dr
    City
    Cincinnati
    State
    OH
    ZIP
    45244
    Country
    US

    Regulatory Submissions

    PMA Number
    P100025

    Owner / Operator

    Firm Name
    MERIDIAN BIOSCIENCE, INC.
    Operator Number
    1524213
    Address
    3471 RIVER HILLS DR., --
    City
    Cincinnati
    State
    OH
    Postal Code
    45244
    Country
    US
    Correspondent
    Susan M Bogar

    Products

    Device Name Product Code
    Test, Urea Adult And Pediatric (Breath), OZA

    Proprietary Names

    BreathTek Urea Breath Test for H. pylori BreathTek Urea Breath Test for H. pylori

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device