Data / Medical devices / United Kingdom / Lex Diagnostics Ltd
Lex Diagnostics Ltd: FDA-registered device maker in Melbourn Hertfordshire, United Kingdom, 1 510(k) clearance
Lex Diagnostics Ltd is registered with the FDA (registration 3044563551) in Melbourn Hertfordshire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044563551
- Address
- Melbourn Science Park, Melbourn Hertfordshire, United Kingdom, SG8 6EE
- Owner or operator
- LEX Diagnostics Ltd (10095349)
- Roles
- Manufacturer
- First device listed
- March 2, 2026
- Registered through
- 2026
- Brand names listed
- NuLexa Influenza + SARS Test, NuLexa Instrument
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2026 | K251742 | VELO Respiratory Test | QOF | Substantially Equivalent | Lex Diagnostics Limited | accessdata.fda.gov |
Compare with other makers
Updated February 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.