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Alinity 04Z2135

by Abbott Ireland

Alinity 04Z2135 is a Class II device made by Abbott Ireland, listed in FDA GUDID since 8 Jul 2022 (UDI-DI 00380740194079), 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 Number00380740194079 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  • Withdrawn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, kit, chemiluminescent immunoassay
Model / Ref / Catalog
04Z2135
Primary DI / UDI-DI
00380740194079
FDA product code
MMI
GMDN term
Troponin I IVD, kit, chemiluminescent immunoassay
Device class
Class II
Regulation number
862.1215
GUDID distribution status
In Commercial Distribution

Related devices

Category: Troponin I IVD, kit, chemiluminescent immunoassay

Other devices from Abbott Ireland

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Properties

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