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Architect 7K65-39

by Abbott Ireland

Part of a family of 9 devices: see the family page

Ref 07K6539

Architect 7K65-39 (07K6539) is a device classified as Class B in the EU and Class II in the US made by Abbott Ireland, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 038074ARK0765NJ) and listed in FDA GUDID since 14 May 2018 (UDI-DI 00380740119812), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ARK0765NJ Basic UDI-DI 00380740119812UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740119812 UDI-DI Date14 May 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARK0765NJ registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740119812 listed 14 May 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740119812
  2. Registered EUDAMED 038074ARK0765NJ

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  • Withdrawn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
Architect
Generic name
Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Device name
ARCHITECT Free T4
Model / Ref / Catalog
07K6539, 7K65-39
Primary DI / UDI-DI
00380740119812
Basic UDI-DI
038074ARK0765NJ
FDA product code
CEC
EMDN code
W01020402 Free thyroxine
GMDN term
Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1695
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
07K6539
GUDID
7K65-39
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: Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

Similar devices in this category

Other devices filed under FREE THYROXINE.

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)