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Alinity 09P8420

by Abbott Laboratories

Ref 09P8420

Alinity 09P8420 is a device classified as Class A in the EU and Class I in the US made by Abbott Laboratories, registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI 038074DTB0001KX) and listed in FDA GUDID since 16 Nov 2023 (UDI-DI 00380740132552), active as of 7 Nov 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074DTB0001KX Basic UDI-DI 00380740132552UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740132552 UDI-DI Date16 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074DTB0001KX registered 24 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740132552 listed 16 Nov 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00380740132552
  2. Registered EUDAMED 038074DTB0001KX

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  • Withdrawn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
General specimen microscopy slide IVD, single-use
Model / Ref / Catalog
09P8420
Primary DI / UDI-DI
00380740132552
Basic UDI-DI
038074DTB0001KX
FDA product code
KEW
EMDN code
W02029085 Various hematology / histology / cytology instruments - consumables
GMDN term
General specimen microscopy slide IVD, single-use
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.3010
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 A
GUDID
Class I

Device class is stated on each registry's own scale: Class A 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: General specimen microscopy slide IVD, single-use

Similar devices in this category

Other devices filed under VARIOUS HEMATOLOGY / HISTOLOGY /CYTOLOGY INSTRUMENTS.

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

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