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Architect 08G9826

by Abbott Laboratories

Architect 08G9826 is a Class I device made by Abbott Laboratories, listed in FDA GUDID since 2 Aug 2025 (UDI-DI 00380740220495), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00380740220495 UDI-DI Date2 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

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  • Withdrawn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
Laboratory instrument/analyser application software IVD
Model / Ref / Catalog
08G9826
Primary DI / UDI-DI
00380740220495
FDA product code
JJE
GMDN term
Laboratory instrument/analyser application software IVD
Device class
Class I
Regulation number
862.2160
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)