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Architect 04T0330

by Abbott Ireland

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 Number00380740195243 UDI-DI Date19 Dec 2025ListedStatusListed 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  • Withdrawn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
Architect
Generic Name
Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
Model / Ref / Catalog
04T0330
Primary DI / UDI-DI
00380740195243
FDA Product Code
CFJ
GMDN Term
Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
Device Class
Class II
Regulation Number
862.1440
GUDID distribution status
In Commercial Distribution

Other devices from Abbott Ireland

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Properties

  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No