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Alinity 07P4820

by Abbott Ireland

Part of a family of 7 devices: see the family page

Ref 07P4820

Alinity 07P4820 is a device classified as Class B in the EU and Class II in the US made by Abbott Ireland, registered in EUDAMED on 23 Aug 2026 (Basic UDI-DI 038074AIP0748LL) and listed in FDA GUDID since 31 May 2018 (UDI-DI 00380740131142), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074AIP0748LL Basic UDI-DI 00380740131142UDI-DIDate23 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740131142 UDI-DI Date31 May 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074AIP0748LL registered 23 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740131142 listed 31 May 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740131142
  2. Registered EUDAMED 038074AIP0748LL

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  • Withdrawn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
Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Device name
Alinity i TSH Reagent Kit
Model / Ref / Catalog
07P4820
Primary DI / UDI-DI
00380740131142
Basic UDI-DI
038074AIP0748LL
FDA product code
JLW
EMDN code
W01020410 Thyroid stimulating hormone
GMDN term
Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1690
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 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: Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Similar devices in this category

Other devices filed under THYROID STIMULATING HORMONE.

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)