BEUDAMED
    FDA Registration Active 🇳🇴 Norway

    Cystatin C Immunoassay

    Reg #: 3006801241 · FEI: 3006801241 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Gentian AS
    Registration Number
    3006801241
    FEI Number
    3006801241
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bjornasveien 5
    City
    Moss Ostfold
    Country
    NO

    Regulatory Submissions

    510(k) Number
    K081875

    Owner / Operator

    Firm Name
    Gentian AS
    Operator Number
    10023325
    Address
    15696 Oakstand Road
    City
    Poway
    State
    CA
    Postal Code
    92064
    Country
    US

    US Agent

    Business Name
    E4 Consulting
    Contact Name
    Eric S Gruff
    Address
    15696 Oakstand Rd
    City
    Poway
    State
    CA
    ZIP
    92064
    Country
    US
    Email
    [email protected]
    Phone
    858 7350320

    Products

    Device Name Product Code
    Test, Cystatin C NDY

    Proprietary Names

    Cystatin C Immunoassay

    Establishment Types

    Manufacture Medical Device