Skip to content

Architect 04T0320

by Abbott Ireland

Architect 04T0320 is a Class II device made by Abbott Ireland, listed in FDA GUDID since 19 Dec 2025 (UDI-DI 00380740195236), 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 Number00380740195236 UDI-DI Date19 Dec 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  • Withdrawn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
Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
Model / Ref / Catalog
04T0320
Primary DI / UDI-DI
00380740195236
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

Similar devices

Other devices filed under FDA product code CFJ (NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE).

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)