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Alinity 04T8420

by Abbott Ireland

Ref 04T8420

Alinity 04T8420 is a device classified as Class B in the EU and Class I in the US made by Abbott Ireland, registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI 038074EAT0484LH) and listed in FDA GUDID since 14 Jun 2022 (UDI-DI 00380740155704), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074EAT0484LH Basic UDI-DI 00380740155704UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740155704 UDI-DI Date14 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074EAT0484LH registered 18 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740155704 listed 14 Jun 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740155704
  2. Registered EUDAMED 038074EAT0484LH

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Alinity
Generic name
Alanine aminotransferase (ALT) IVD, reagent
Device name
Alanine Aminotransferase2
Model / Ref / Catalog
04T8420
Primary DI / UDI-DI
00380740155704
Basic UDI-DI
038074EAT0484LH
FDA product code
CKA
EMDN code
W01010103 Alanine amino-transferase
GMDN term
Alanine aminotransferase (ALT) IVD, reagent
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1030
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class I

Device class is stated on each registry's own scale: Class B in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Alanine aminotransferase (ALT) IVD, reagent

Similar devices in this category

Other devices filed under ALANINE AMINO-TRANSFERASE.

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)