BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Testosterone ELISA

    Reg #: 3005542422 · FEI: 3005542422 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DEMEDITEC DIAGNOSTICS GmbH
    Registration Number
    3005542422
    FEI Number
    3005542422
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LISE-MEITNER-STRASSE 2
    City
    KIEL-WELLSEE Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K000043

    Owner / Operator

    Firm Name
    DEMEDITEC DIAGNOSTICS
    Operator Number
    9083404
    Address
    LISE-MEITNER-STRASSE 2, --
    City
    KIEL-WELLSEE
    State
    DE-NOTA
    Postal Code
    D-24145
    Country
    DE

    US Agent

    Business Name
    Immuno-Biological Laboratories, Inc. (IBL-America)
    Contact Name
    Mark Kowal
    Address
    8201 Central Ave NE, Suite P
    City
    Minneapolis
    State
    MN
    ZIP
    55432
    Country
    US
    Email
    [email protected]
    Phone
    763 7802955

    Products

    Device Name Product Code
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ

    Proprietary Names

    Testosterone ELISA

    Establishment Types

    Repack or Relabel Medical Device