BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    LIAISON EASY Starter kit (319300)

    Reg #: 3004434309 · FEI: 3004434309 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DiaSorin Deutschland GmbH
    Registration Number
    3004434309
    FEI Number
    3004434309
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Von-Hevesy-Str. 3
    City
    Dietzenbach Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K193532

    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
    Hepatitis A Test (Antibody And Igm Antibody) LOL
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    LIAISON EASY Starter kit (319300) LIAISON Disposable Tips (x0055) LIAISON XS Analyzer LIAISON Cuvettes on tray (X0053) LIAISON EASY Wash Buffer (319301) LIAISON EASY Cleaning Tool (310996) LIAISON Anti-HAV LIAISON EASY System Liquid

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)