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Architect 8G67-02

by Abbott Laboratories

Ref 08G6702Model 8G67-02

Architect 8G67-02 (08G6702) is a device classified as IVD General (EU), Class II (US) made by Abbott Laboratories, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00380740028473) and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740028473), 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-00380740028473 Basic UDI-DI 00380740028473UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740028473 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740028473 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00380740028473 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740028473
  2. Registered EUDAMED B-00380740028473

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  • Withdrawn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
Rheumatoid factor IVD, calibrator
Model / Ref / Catalog
8G67-02, 08G6702
Primary DI / UDI-DI
00380740028473
Basic UDI-DI
B-00380740028473
FDA product code
DHR
EMDN code
W0102152210 Standards and calibrators for rheumatology
GMDN term
Rheumatoid factor IVD, calibrator
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.5775
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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: Rheumatoid factor IVD, calibrator

Similar devices in this category

Other devices filed under STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY.

Other devices from Abbott Laboratories

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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)