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Alinity 04T8630

by Abbott Ireland

Ref 04T8630

Alinity 04T8630 is an in vitro diagnostic device (EU IVDR Class B; FDA Class II; FDA product code CIT, Nadh oxidation/nad reduction, ast/sgot) made by Abbott Ireland, registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI 038074ACT0486KB) and listed in FDA GUDID since 14 Jun 2022 (UDI-DI 00380740158064), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ACT0486KB Basic UDI-DI 00380740158064UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740158064 UDI-DI Date14 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ACT0486KB registered 18 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740158064 listed 14 Jun 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740158064
  2. Registered EUDAMED 038074ACT0486KB

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  • Withdrawn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
Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Device name
Aspartate Aminotransferase2
Model / Ref / Catalog
04T8630
Primary DI / UDI-DI
00380740158064
Basic UDI-DI
038074ACT0486KB
FDA product code
CIT
EMDN code
W01010110 Aspartate amino-transferase
GMDN term
Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1100
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 II

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

Related devices

Category: Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry

Similar devices in this category

Other devices filed under ASPARTATE 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)