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Alinity 08P5001

by Abbott

Part of a family of 6 devices: see the family page

Ref 08P5001

Alinity 08P5001 is a device classified as Class C in the EU and Class II in the US made by Abbott, registered in EUDAMED on 23 Aug 2026 (Basic UDI-DI 038074AIP0850LC) and listed in FDA GUDID since 3 Jan 2019 (UDI-DI 00380740131067), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074AIP0850LC Basic UDI-DI 00380740131067UDI-DIDate23 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740131067 UDI-DI Date3 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074AIP0850LC registered 23 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740131067 listed 3 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740131067
  2. Registered EUDAMED 038074AIP0850LC

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  • Withdrawn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
Human epididymis protein 4 (HE4) IVD, calibrator
Device name
Alinity i HE4
Model / Ref / Catalog
08P5001
Primary DI / UDI-DI
00380740131067
Basic UDI-DI
038074AIP0850LC
FDA product code
JIT
EMDN code
W0102152205 Tumour marker standards and calibrators
GMDN term
Human epididymis protein 4 (HE4) IVD, calibrator
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class II

Device class is stated on each registry's own scale: Class C 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: Human epididymis protein 4 (HE4) IVD, calibrator

Similar devices in this category

Other devices filed under TUMOUR MARKER STANDARDS AND CALIBRATORS.

Other devices from Abbott

See all devices from Abbott →

Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)