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Architect 7K64-35

by Abbott Ireland

Ref 07K6435Model 7K64-35

Architect 7K64-35 (07K6435) is a device classified as IVD General (EU), Class I (US) made by Abbott Ireland, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00380740105945) and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740105945), 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-00380740105945 Basic UDI-DI 00380740105945UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740105945 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740105945 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740105945 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740105945
  2. Registered EUDAMED B-00380740105945

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  • Withdrawn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
Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
Device name
Total T3
Model / Ref / Catalog
7K64-35, 07K6435
Primary DI / UDI-DI
00380740105945
Basic UDI-DI
B-00380740105945
FDA product code
JJX, JIT, CDP
EMDN code
W01020405 Triiodothyronine
GMDN term
Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1660, 862.1150, 862.1710
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: Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

Similar devices in this category

Other devices filed under TRIIODOTHYRONINE.

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)