BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    LEX DIAGNOSTICS LTD

    Reg #: 3044563551 · FEI: 3044563551 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LEX DIAGNOSTICS LTD
    Registration Number
    3044563551
    FEI Number
    3044563551
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Melbourn Science Park
    City
    Melbourn Hertfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K251742

    Owner / Operator

    Firm Name
    LEX Diagnostics Ltd
    Operator Number
    10095349
    Address
    Melbourn Science Park
    City
    Melbourn
    State
    Hertfordshire
    Postal Code
    SG8 6EE
    Country
    GB
    Correspondent
    Edward Farrell

    US Agent

    Business Name
    Ortho-Clinical Diagnostics, Inc.
    Contact Name
    Raquel Almeida
    Address
    1001 Us Highway 202
    City
    Raritan
    State
    NJ
    ZIP
    08869
    Country
    US
    Email
    [email protected]
    Phone
    908 7046825

    Products

    Device Name Product Code
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF

    Proprietary Names

    NuLexa Influenza + SARS Test NuLexa Instrument

    Establishment Types

    Manufacture Medical Device