BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DiaSorin Deutschland GmbH

    Reg #: 3004434309 · FEI: 3004434309 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    41
    Establishment Types
    1
    Classifications
    16

    Registration Details

    Registration Name
    DiaSorin Deutschland GmbH
    Registration Number
    3004434309
    FEI Number
    3004434309
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Von-Hevesy-Str. 3
    City
    Dietzenbach Hesse
    Country
    DE

    Owner / Operator

    Firm Name
    DiaSorin Inc.
    Operator Number
    9051149
    Address
    1951 Northwestern Ave
    City
    Stillwater
    State
    MN
    Postal Code
    55082
    Country
    US
    Correspondent
    Mari Meyer

    US Agent

    Business Name
    DiaSorin Inc.
    Contact Name
    Mari Meyer
    Address
    1951 Northwestern Ave
    City
    Stillwater
    State
    MN
    ZIP
    55082
    Country
    US
    Email
    [email protected]
    Phone
    651 4939971

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Radioimmunoassay, Luteinizing Hormone CEP
    Radioimmunoassay, Total Triiodothyronine CDP
    Radioimmunoassay, C-Peptides Of Proinsulin JKD
    Radioimmunoassay, Prolactin (Lactogen) CFT
    System, Test, Human Chorionic Gonadotropin DHA
    Radioimmunoassay, Human Growth Hormone CFL
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Hepatitis A Test (Antibody And Igm Antibody) LOL
    Radioimmunoassay, Free Thyroxine CEC
    Ferritin, Antigen, Antiserum, Control DBF
    Research Use Only/Immunology Devices OTR
    Radioimmunoassay, Immunoreactive Insulin CFP
    Analyzer, Chemistry, Micro, For Clinical Use JJF
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ

    Proprietary Names

    LIAISON TSH LIAISON LH LIAISON FT3 LIAISON C-Peptid LIAISON Prolactin xt LIAISON® XL HCG HUMAN GROWTH HORMONE LIAISON hGH LIAISON hGH control set LIAISON IGF-1 LIAISON XS Analyzer LIAISON Disposable Tips (x0055) LIAISON EASY Starter kit (319300) LIAISON EASY Wash Buffer (319301) LIAISON Anti-HAV LIAISON Cuvettes on tray (X0053) LIAISON EASY System Liquid LIAISON EASY Cleaning Tool (310996) LIAISON Control Thyroid 1, LIAISON Control Thyroid 2, LIAISON Control Thyroid 3 LIAISON FT4 LIAISON Control Ferritin LIAISON Ferritin LIAISON Ferritin Calibration Verifiers S100B ELISA TK-REA LIAISON NSE LIAISON TK LIAISON Insulin LIAISON Insulin Control Set LIAISON Endocrinology Diluent LIAISON® diluteX LIAISON Light Check LIAISON Wash/System Liquid LIAISON XL Clean Tool LIAISON Light Check 12 LIAISON Starter kit LIAISON Clean Kit LIAISON XL Starter kit LIAISON Analyzer LIAISON XL Analyzer LIAISON FSH

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)