Skip to content

Alinity 04Z2101

by Abbott Ireland

Alinity 04Z2101 is a Class II device made by Abbott Ireland, listed in FDA GUDID since 8 Jul 2022 (UDI-DI 00380740194048), 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 Number00380740194048 UDI-DI Date8 Jul 2022ListedStatusListed 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  • Withdrawn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
Alinity
Generic name
Troponin I IVD, calibrator
Model / Ref / Catalog
04Z2101
Primary DI / UDI-DI
00380740194048
FDA product code
JIT
GMDN term
Troponin I IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Troponin I IVD, calibrator

Similar devices

Other devices filed under FDA product code JIT (Calibrator, secondary).

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)