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Alinity 09P3501

by Abbott Ireland Diagnostics

Ref 09P3501

Alinity 09P3501 is a device classified as Class B in the EU and Class II in the US made by Abbott Ireland Diagnostics, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 038074AIP0935LM) and listed in FDA GUDID since 10 Aug 2018 (UDI-DI 00380740150594), 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 Number038074AIP0935LM Basic UDI-DI 00380740150594UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740150594 UDI-DI Date10 Aug 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074AIP0935LM registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740150594 listed 10 Aug 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740150594
  2. Registered EUDAMED 038074AIP0935LM

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  • Withdrawn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
Multiple thyroid antibody IVD, calibrator
Device name
Alinity i Anti-TPO
Model / Ref / Catalog
09P3501
Primary DI / UDI-DI
00380740150594
Basic UDI-DI
038074AIP0935LM
FDA product code
JIT
EMDN code
W0102152211 Standards and calibrators for autoimmunity
GMDN term
Multiple thyroid antibody IVD, calibrator
Device class
Class B 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 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: Multiple thyroid antibody IVD, calibrator

Similar devices in this category

Other devices filed under STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY.

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (15, all answered No)