BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Serum CrossLaps® (CTX-I) ELISA

    Reg #: 8021924 · FEI: 3002485711 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IMMUNODIAGNOSTIC SYSTEMS LTD.
    Registration Number
    8021924
    FEI Number
    3002485711
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10 DIDCOT WAY
    City
    Boldon Colliery Durham
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K990843

    Owner / Operator

    Firm Name
    IMMUNODIAGNOSTIC SYSTEMS LTD.
    Operator Number
    8021924
    Address
    10 DIDCOT WAY, BOLDON BUSINESS PARK
    City
    BOLDON COLLIERY
    State
    GB-NOTA
    Postal Code
    NE35 9PD
    Country
    GB

    US Agent

    Business Name
    Euroimmun US Inc.
    Contact Name
    Faith Du
    Address
    1 Bloomfield Avenue
    City
    Mountain Lakes
    State
    NJ
    ZIP
    07046
    Country
    US
    Email
    [email protected]
    Phone
    800 9132022 ext. 118

    Products

    Device Name Product Code
    Column Chromatography & Color Development, Hydroxyproline JMM

    Proprietary Names

    Serum CrossLaps® (CTX-I) ELISA

    Establishment Types

    Manufacture Medical Device