Skip to content

Alinity 09P4720

by Abbott

Ref 09P4720

Alinity 09P4720 is a device classified as Class B in the EU and Class II in the US made by Abbott, registered in EUDAMED on 23 Aug 2026 (Basic UDI-DI 038074ACP0947JE) and listed in FDA GUDID since 9 Sep 2019 (UDI-DI 00380740154509), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ACP0947JE Basic UDI-DI 00380740154509UDI-DIDate23 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740154509 UDI-DI Date9 Sep 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ACP0947JE registered 23 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740154509 listed 9 Sep 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740154509
  2. Registered EUDAMED 038074ACP0947JE

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  • Withdrawn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
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
09P4720
Primary DI / UDI-DI
00380740154509
Basic UDI-DI
038074ACP0947JE
FDA product code
DFC
EMDN code
W0102010403 Apolipoprotein b
GMDN term
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Device class
Class B EUDAMED
Class II GUDID
Regulation number
866.5600
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: Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

Similar devices in this category

Other devices filed under APOLIPOPROTEIN B.

Other devices from Abbott

See all devices from Abbott →

Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)