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Architect 7D73-22

by Abbott

Ref 07D7322Model 7D73-22

Architect 7D73-22 (07D7322) is a device classified as IVD General (EU), Class II (US) made by Abbott, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00380740161750) and listed in FDA GUDID since 24 Oct 2019 (UDI-DI 00380740161750), 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-00380740161750 Basic UDI-DI 00380740161750UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740161750 UDI-DI Date24 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740161750 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740161750 listed 24 Oct 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740161750
  2. Registered EUDAMED B-00380740161750

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  • Withdrawn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
Total protein IVD, reagent
Model / Ref / Catalog
7D73-22, 07D7322
Primary DI / UDI-DI
00380740161750
Basic UDI-DI
B-00380740161750
FDA product code
CEK
EMDN code
W01010230 Total protein
GMDN term
Total protein IVD, reagent
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1635
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: Total protein IVD, reagent

Similar devices in this category

Other devices filed under TOTAL PROTEIN.

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Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)