BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    IMAGEN Herpes Simplex Virus kit

    Reg #: 3003750284 · FEI: 3003750284 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    REMEL EUROPE LTD
    Registration Number
    3003750284
    FEI Number
    3003750284
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    REMEL HOUSE, CLIPPER BLVD., WEST CROSSWAYS
    City
    DARTFORD, KENT
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K870602

    Owner / Operator

    Firm Name
    Thermo Fisher Scientific
    Operator Number
    2517925
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    US Agent

    Business Name
    Remel, Inc.
    Contact Name
    Alycia Jayroe
    Address
    12076 Santa Fe Trail
    City
    Lenexa
    State
    KS
    ZIP
    66215
    Country
    US
    Email
    [email protected]
    Phone
    913 8954063

    Products

    Device Name Product Code
    Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 GQN

    Proprietary Names

    IMAGEN Herpes Simplex Virus kit K610611-2 IMAGEN HSV Kit (50 tests)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)