BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Lyme ELISA (IgG/IgM)

    Reg #: 3003268355 · FEI: 3003268355 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
    Registration Number
    3003268355
    FEI Number
    3003268355
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    EUROIMMUN AG, Seekamp 31
    City
    Luebeck Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K142038

    Owner / Operator

    Firm Name
    EUROIMMUN Medizinische Labordiagnostika AG
    Operator Number
    10025212
    Address
    EUROIMMUN AG, Seekamp 31
    City
    Luebeck
    State
    Schleswig-Holstein
    Postal Code
    D-23560
    Country
    DE
    Correspondent
    Stephan Maihold

    Products

    Device Name Product Code
    Reagent, Borrelia Serological Reagent LSR

    Proprietary Names

    Lyme ELISA (IgG/IgM)

    Establishment Types

    Manufacture Medical Device