BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OMNIgene-GUT (OMD-200)

    Reg #: 3004142665 · FEI: 3004142665 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORASURE TECHNOLOGIES INC.
    Registration Number
    3004142665
    FEI Number
    3004142665
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    220 EAST FIRST STREET
    City
    BETHLEHEM
    State
    PA
    ZIP
    18015
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN200040

    Owner / Operator

    Firm Name
    ORASURE TECHNOLOGIES, INC.
    Operator Number
    9000083
    Address
    220 EAST FIRST STREET, --
    City
    Bethlehem
    State
    PA
    Postal Code
    18015
    Country
    US
    Correspondent
    Tiffany A Miller

    Products

    Device Name Product Code
    Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples QPO

    Proprietary Names

    OMNIgene-GUT (OMD-200)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)