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NuLexa 100002

by Lex Diagnostics Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05061098480032 UDI-DI Date24 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
NuLexa
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Model / Ref / Catalog
100002
Primary DI / UDI-DI
05061098480032
FDA Product Code
QOF
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Device Class
Class II
Regulation Number
866.3981
GUDID distribution status
In Commercial Distribution

Other devices from Lex Diagnostics Limited

Properties

  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No