BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Trep-Sure

    Reg #: 1318354 · FEI: 1318354 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Trinity Biotech USA
    Registration Number
    1318354
    FEI Number
    1318354
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2823 Girts Rd
    City
    Jamestown
    State
    NY
    ZIP
    14701
    Country
    US

    Regulatory Submissions

    510(k) Number
    K001552

    Owner / Operator

    Firm Name
    TRINITY BIOTECH, PLC
    Operator Number
    9025161
    Address
    2823 Girts Rd
    City
    Jamestown
    State
    NY
    Postal Code
    14701
    Country
    US

    Products

    Device Name Product Code
    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum LIP

    Proprietary Names

    Trep-Sure

    Establishment Types

    Manufacture Medical Device