BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    T-Cell Xtend reagent

    Reg #: 3015492990 · FEI: 3015492990 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OXFORD IMMUNOTEC LTD
    Registration Number
    3015492990
    FEI Number
    3015492990
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    143 Park Drive East, Milton Park
    City
    Abingdon Oxfordshire
    Country
    GB

    Regulatory Submissions

    PMA Number
    P070006

    Owner / Operator

    Firm Name
    Oxford Immunotec Ltd
    Operator Number
    10026700
    Address
    143 Park Drive East, Milton Park
    City
    Abingdon
    State
    Oxfordshire
    Postal Code
    OX14 4SE
    Country
    GB
    Correspondent
    Christopher Dark

    US Agent

    Business Name
    New World Regulatory Solutions, Inc.
    Contact Name
    Maureen Garner
    Address
    11222 Corsica Mist Avenue
    City
    Las Vegas
    State
    NV
    ZIP
    89135
    Country
    US
    Email
    [email protected]
    Phone
    732 7797422

    Products

    Device Name Product Code
    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test OJN

    Proprietary Names

    T-Cell Xtend reagent T-SPOT.TB Test T-Cell Select reagent

    Establishment Types

    Manufacture Medical Device