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Architect 3E16-02

by Abbott Laboratories

Architect 3E16-02 (03E1602) is a lipase IVD (FDA Class II; FDA product code JIX, Calibrator, Multi-Analyte Mixture) made by Abbott Laboratories, listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740004859), 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 Number00380740004859 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  • Withdrawn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
Lipase IVD, calibrator
Model / Ref / Catalog
3E16-02, 03E1602
Primary DI / UDI-DI
00380740004859
FDA product code
JIX
GMDN term
Lipase IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Lipase IVD, calibrator

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

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