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Architect 07K6402

by Abbott Ireland

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

Ref 07K6402

Architect 07K6402 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 038074ARK0764NG) and listed in FDA GUDID since 26 Jun 2020 (UDI-DI 00380740144845), 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 Number038074ARK0764NG Basic UDI-DI 00380740144845UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740144845 UDI-DI Date26 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARK0764NG registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740144845 listed 26 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740144845
  2. Registered EUDAMED 038074ARK0764NG

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  • Withdrawn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
Total triiodothyronine (TT3) IVD, calibrator
Device name
ARCHITECT Total T3
Model / Ref / Catalog
07K6402
Primary DI / UDI-DI
00380740144845
Basic UDI-DI
038074ARK0764NG
FDA product code
JIT
EMDN code
W0102152208 Standards and calibrators for individual and specific hormones /proteins
GMDN term
Total triiodothyronine (TT3) IVD, calibrator
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1150
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: Total triiodothyronine (TT3) IVD, calibrator

Similar devices in this category

Other devices filed under STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS.

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
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)