BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Gold Standard Diagnostics Borrelia Burgdorferi Igg ELISA Test Kit

    Reg #: 3008191245 · FEI: 3008191245 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Gold Standard Diagnostics Frankfurt GmbH
    Registration Number
    3008191245
    FEI Number
    3008191245
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Waldstrasse 23 A6
    City
    Dietzenbach Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K203296

    Owner / Operator

    Firm Name
    Gold Standard Diagnostics
    Operator Number
    10031124
    Address
    Waldstrasse 23 A6
    City
    Dietzenbach
    State
    Hesse
    Postal Code
    63128
    Country
    DE
    Correspondent
    Natalie J Kennel

    US Agent

    Business Name
    NJK & Associates Inc
    Contact Name
    Natalie Kennel
    Address
    13721 Via Tres Vis
    City
    San Diego
    State
    CA
    ZIP
    92129
    Country
    US
    Email
    [email protected]
    Phone
    858 7050350

    Products

    Device Name Product Code
    Reagent, Borrelia Serological Reagent LSR

    Proprietary Names

    Gold Standard Diagnostics Borrelia Burgdorferi Igg ELISA Test Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)