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Alinity 07P8104

by Abbott Laboratories

Ref 07P8104

Alinity 07P8104 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 038074HSP0781UB) and listed in FDA GUDID since 16 Nov 2023 (UDI-DI 00380740136963), 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 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/IVDR EUDAMED Number038074HSP0781UB Basic UDI-DI 00380740136963UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740136963 UDI-DI Date16 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074HSP0781UB registered 24 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740136963 listed 16 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740136963
  2. Registered EUDAMED 038074HSP0781UB

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  • Withdrawn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
Blood cell lysis reagent IVD
Model / Ref / Catalog
07P8104
Primary DI / UDI-DI
00380740136963
Basic UDI-DI
038074HSP0781UB
FDA product code
GGK
EMDN code
W01030199 Haematology reagents - other
GMDN term
Blood cell lysis reagent IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.8540
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: Blood cell lysis reagent IVD

Similar devices in this category

Other devices filed under HAEMATOLOGY REAGENTS - OTHER.

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

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