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Alinity 04U0320

by Abbott Ireland

Ref 04U0320

Alinity 04U0320 is an in vitro diagnostic device (EU IVDR Class B; FDA Class I; FDA product code CEO, Phosphomolybdate (colorimetric), inorganic phosphorus) made by Abbott Ireland, registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI 038074ACU0403JQ) and listed in FDA GUDID since 11 Mar 2024 (UDI-DI 00380740155643), 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 Number038074ACU0403JQ Basic UDI-DI 00380740155643UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740155643 UDI-DI Date11 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ACU0403JQ registered 18 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740155643 listed 11 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740155643
  2. Registered EUDAMED 038074ACU0403JQ

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  • Withdrawn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
Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Device name
Phosphorus2
Model / Ref / Catalog
04U0320
Primary DI / UDI-DI
00380740155643
Basic UDI-DI
038074ACU0403JQ
FDA product code
CEO
EMDN code
W01010307 Phosphate inorganic / phosphorus
GMDN term
Inorganic phosphate (PO43-) IVD, kit, spectrophotometry
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1580
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: Inorganic phosphate (PO43-) IVD, kit, spectrophotometry

Similar devices in this category

Other devices filed under PHOSPHATE INORGANIC / PHOSPHORUS.

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • New device
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)