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Architect 7D81-21

by Abbott Laboratories

Architect 7D81-21 (07D8121) is a Class II device made by Abbott Laboratories, listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740013059), 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 Number00380740013059 UDI-DI Date9 Sep 2016ListedStatusListed 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  • Withdrawn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
Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Model / Ref / Catalog
7D81-21, 07D8121
Primary DI / UDI-DI
00380740013059
FDA product code
CIT
GMDN term
Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Device class
Class II
Regulation number
862.1100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry

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Properties

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