BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Anti-Jo-1 ELISA (IgG)

    Reg #: 3007361513 · FEI: 3007361513 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    EUROIMMUN Medizinische Labordiagnostika AG
    Registration Number
    3007361513
    FEI Number
    3007361513
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    EUROIMMUN AG, Werkstrasse 1
    City
    Dassow Mecklenburg-Western Pomerania
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K123261

    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
    Anti-Rnp Antibody, Antigen And Control LKO
    Anti-Ribosomal P Antibodies MQA
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Anti-Sm Antibody, Antigen And Control LKP
    Extractable Antinuclear Antibody, Antigen And Control LLL

    Proprietary Names

    Anti-Jo-1 ELISA (IgG) Anti-Centromeres ELISA (IgG) Anti-ribosomal P Proteins ELISA (IgG) Anti-SS-B ELISA (IgG) Anti-Sm ELISA (IgG) Anti-SS-A ELISA (IgG) Anti-nRNP/Sm ELISA (IgG) Anti-Scl-70 ELISA (IgG)

    Establishment Types

    Manufacture Medical Device