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NuLexa 200003

by Lex Diagnostics Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number05061098480025 UDI-DI Date24 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Oral/respiratory tract specimen container IVD, additive/medium
Model / Ref / Catalog
200003
Primary DI / UDI-DI
05061098480025
510(k) Number
FDA Product Code
QOF
GMDN Term
Oral/respiratory tract specimen container IVD, additive/medium
Device Class
Class II
Regulation Number
866.3981
GUDID distribution status
In Commercial Distribution

Other devices from Lex Diagnostics Limited

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No