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Alinity 07P5010

by Abbott Ireland

Part of a family of 8 devices: see the family page

Ref 07P5010

Alinity 07P5010 is a device classified as Class B in the EU and Class I in the US made by Abbott Ireland, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 038074AIP0750L7) and listed in FDA GUDID since 31 Jul 2018 (UDI-DI 00380740129903), 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 Number038074AIP0750L7 Basic UDI-DI 00380740129903UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740129903 UDI-DI Date31 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074AIP0750L7 registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740129903 listed 31 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740129903
  2. Registered EUDAMED 038074AIP0750L7

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  • Withdrawn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
Estradiol (oestradiol) (E2) IVD, control
Device name
Alinity i Estradiol Reagent Kit
Model / Ref / Catalog
07P5010
Primary DI / UDI-DI
00380740129903
Basic UDI-DI
038074AIP0750L7
FDA product code
JJX
EMDN code
W0102152008 Controls for individual and specific hormones
GMDN term
Estradiol (oestradiol) (E2) IVD, control
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1660
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 B
GUDID
Class I

Device class is stated on each registry's own scale: Class B 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: Estradiol (oestradiol) (E2) IVD, control

Similar devices in this category

Other devices filed under CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES.

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

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)