Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044563551

FEI Number

3044563551

Entity Name

LEX DIAGNOSTICS LTD

City/State/Country

Melbourn Hertfordshire, GB

Establishment Address

Melbourn Science Park, Melbourn Hertfordshire SG8 6EE, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LEX Diagnostics Ltd (Owner Number: 10095349)

Owner / Operator Contact Address

Melbourn Science Park, Melbourn, GB-HRT SG8 6EE, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251742

PMA Number

N/A

All Registered Proprietary Names

NuLexa Influenza + SARS Test NuLexa Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2026-03-02

Official Correspondent

Edward Farrell

US Agent Details

Raquel Almeida Business: Ortho-Clinical Diagnostics, Inc. Email: orthocompliance@quidelortho.com Phone: (908) 7046825

Related Public Records

Same Entity

LEX Diagnostics Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044563551. Last updated year: 2026. Please use registration number 3044563551 when referencing this establishment in official correspondence.