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Architect 08G6624

by Abbott Ireland

Ref 08G6624

Architect 08G6624 is a device classified as Class B in the EU and Class II in the US made by Abbott Ireland, registered in EUDAMED on 23 Aug 2026 (Basic UDI-DI 038074LFD0015KJ) and listed in FDA GUDID since 13 Sep 2024 (UDI-DI 00380740170004), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074LFD0015KJ Basic UDI-DI 00380740170004UDI-DIDate23 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740170004 UDI-DI Date13 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074LFD0015KJ registered 23 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740170004 listed 13 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740170004
  2. Registered EUDAMED 038074LFD0015KJ

Coverage

2 jurisdictions

United States of AmericaNorwayIcelandSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaLiechtensteinAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Map note: Northern Ireland has no dot of its own.

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Northern Ireland
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden

Specification

EUDAMED · GUDID

Trade name
Architect
Generic name
Rheumatoid factor IVD, kit, nephelometry/turbidimetry
Device name
Rheumatoid Factor
Model / Ref / Catalog
08G6624
Primary DI / UDI-DI
00380740170004
Basic UDI-DI
038074LFD0015KJ
FDA product code
DHR
EMDN code
W01021110 Rheumatoid factors
GMDN term
Rheumatoid factor IVD, kit, nephelometry/turbidimetry
Device class
Class B EUDAMED
Class II GUDID
Regulation number
866.5775
EU registration type
Standard device
EU market of registration
Germany
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: Rheumatoid factor IVD, kit, nephelometry/turbidimetry

Similar devices in this category

Other devices filed under RHEUMATOID FACTORS.

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)