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Alinity 08P4020

by Abbott

Ref 08P4020

Alinity 08P4020 is an in vitro diagnostic device (EU IVDD general IVD; FDA Class I; FDA product code CEO, Phosphomolybdate (colorimetric), inorganic phosphorus) made by Abbott, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00380740135126) and listed in FDA GUDID since 11 Jul 2018 (UDI-DI 00380740135126), active as of 7 Nov 2026.

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

CE IVDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00380740135126 Basic UDI-DI 00380740135126UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740135126 UDI-DI Date11 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740135126 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740135126 listed 11 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740135126
  2. Registered EUDAMED B-00380740135126

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Alinity
Generic name
Inorganic phosphate (PO43-) IVD, reagent
Model / Ref / Catalog
08P4020
Primary DI / UDI-DI
00380740135126
Basic UDI-DI
B-00380740135126
FDA product code
CEO
EMDN code
W01010307 Phosphate inorganic / phosphorus
GMDN term
Inorganic phosphate (PO43-) IVD, reagent
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1580
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General 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, reagent

Similar devices in this category

Other devices filed under PHOSPHATE INORGANIC / PHOSPHORUS.

Other devices from Abbott

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Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)