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Architect 9D93-22

by Abbott

Ref 09D9322

Architect 9D93-22 (09D9322) is a device classified as Class B in the EU and Class II in the US made by Abbott, registered in EUDAMED on 23 Aug 2026 (Basic UDI-DI 038074ARD0993LL) and listed in FDA GUDID since 15 Dec 2020 (UDI-DI 00380740175146), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ARD0993LL Basic UDI-DI 00380740175146UDI-DIDate23 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740175146 UDI-DI Date15 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARD0993LL registered 23 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740175146 listed 15 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740175146
  2. Registered EUDAMED 038074ARD0993LL

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  • Withdrawn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
Architect
Generic name
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Device name
Architect Apolipoprotein B
Model / Ref / Catalog
09D9322, 9D93-22
Primary DI / UDI-DI
00380740175146
Basic UDI-DI
038074ARD0993LL
FDA product code
DFC
EMDN code
W0102010403 Apolipoprotein b
GMDN term
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Device class
Class B EUDAMED
Class II GUDID
Regulation number
866.5600
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
09D9322
GUDID
9D93-22
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: Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

Similar devices in this category

Other devices filed under APOLIPOPROTEIN B.

Other devices from Abbott

See all devices from Abbott →

Properties

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