Skip to content

Architect 8L92-22

by Abbott

Ref 08L9222Model 8L92-22

Architect 8L92-22 (08L9222) is an in vitro diagnostic device (EU IVDD general IVD; FDA Class I; FDA product code CKA, Nadh Oxidation/Nad Reduction, Alt/Sgpt) made by Abbott, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00380740161859) and listed in FDA GUDID since 12 Feb 2020 (UDI-DI 00380740161859), 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-00380740161859 Basic UDI-DI 00380740161859UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740161859 UDI-DI Date12 Feb 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740161859 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740161859 listed 12 Feb 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740161859
  2. Registered EUDAMED B-00380740161859

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  • Withdrawn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
Alanine aminotransferase (ALT) IVD, reagent
Device name
A-Alt
Model / Ref / Catalog
8L92-22, 08L9222
Primary DI / UDI-DI
00380740161859
Basic UDI-DI
B-00380740161859
FDA product code
CKA
EMDN code
W01010103 Alanine amino-transferase
GMDN term
Alanine aminotransferase (ALT) IVD, reagent
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1030
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 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: Alanine aminotransferase (ALT) IVD, reagent

Similar devices in this category

Other devices filed under ALANINE AMINO-TRANSFERASE.

Other devices from Abbott

See all devices from Abbott →

Properties

  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)