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Architect 2K46-01

by Abbott Ireland Diagnostics

Ref 02K4601Model 2K46-01

Architect 2K46-01 (02K4601) is a device classified as IVD General (EU), Class I (US) made by Abbott Ireland Diagnostics, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00380740003418) and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740003418), 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-00380740003418 Basic UDI-DI 00380740003418UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740003418 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740003418 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740003418 listed 6 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740003418
  2. Registered EUDAMED B-00380740003418

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  • Withdrawn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
Thyroglobulin antibody IVD, calibrator
Device name
Anti-Tg
Model / Ref / Catalog
2K46-01, 02K4601
Primary DI / UDI-DI
00380740003418
Basic UDI-DI
B-00380740003418
FDA product code
JJX, JIT, JZO
EMDN code
W0102152011 Controls for autoimmunity
GMDN term
Thyroglobulin antibody IVD, calibrator
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1660, 862.1150, 866.5870
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 I

Device class is stated on each registry's own scale: Class IVD General 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: Thyroglobulin antibody IVD, calibrator

Similar devices in this category

Other devices filed under CONTROLS FOR AUTOIMMUNITY.

Other devices from Abbott Ireland Diagnostics

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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)