BEUDAMED
    FDA Registration Active 🇺🇸 United States

    479900 Alethia Group B Streptococcus External Controls

    Reg #: 1524213 · FEI: 1524213 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    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

    510(k) Number
    K112125

    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
    Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test NJR

    Proprietary Names

    479900 Alethia Group B Streptococcus External Controls 480350 Alethia Group B Streptococcus (GBS) 279900 illumigene Group B Streptococcus External Controls 280350 illumigene Group B Streptococcus (GBS)

    Establishment Types

    Manufacture Medical Device