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Architect 7K63-10

by Abbott Ireland

Ref 07K6310Model 7K63-10

Architect 7K63-10 (07K6310) is a device classified as IVD General (EU), Class II (US) made by Abbott Ireland, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00380740014261) and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740014261), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

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/IVDD EUDAMED NumberB-00380740014261 Basic UDI-DI 00380740014261UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740014261 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740014261 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740014261 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740014261
  2. Registered EUDAMED B-00380740014261

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Architect
Generic name
Free triiodothyronine (FT3) IVD, control
Device name
Free T3
Model / Ref / Catalog
7K63-10, 07K6310
Primary DI / UDI-DI
00380740014261
Basic UDI-DI
B-00380740014261
FDA product code
JIT, CDP, JJX
EMDN code
W0102152208 Standards and calibrators for individual and specific hormones /proteins
GMDN term
Free triiodothyronine (FT3) IVD, control
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150, 862.1710, 862.1660
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General 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 triiodothyronine (FT3) IVD, control

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
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)