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Architect 6K89-20

by Abbott Laboratories

Ref 6K89-20

Architect 6K89-20 (06K8920) is a device classified as Class C in the EU and Class I in the US made by Abbott Laboratories, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 805805668CIAMMO01ZZ018NQK) and listed in FDA GUDID since 31 Jul 2018 (UDI-DI 00380740010768), 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 Number805805668CIAMMO01ZZ018NQK Basic UDI-DI 00380740010768UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740010768 UDI-DI Date31 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805805668CIAMMO01ZZ018NQK registered 10 Sep 2026 Active
  • FDA GUDID UDI-DI 00380740010768 listed 31 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740010768
  2. Registered EUDAMED 805805668CIAMMO01ZZ018NQK

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Ammonia Controls EUDAMED
Architect GUDID
Generic name
Ammonia IVD, control
Device name
Ammonia 1
Model / Ref / Catalog
6K89-20, 06K8920
Primary DI / UDI-DI
00380740010768
Basic UDI-DI
805805668CIAMMO01ZZ018NQK
FDA product code
JJX
EMDN code
W0101050204 Electrolyte controls
GMDN term
Ammonia IVD, control
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class I

Device class is stated on each registry's own scale: Class C 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: Ammonia IVD, control

Similar devices in this category

Other devices filed under ELECTROLYTE CONTROLS.

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)