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Architect 7D58-22

by Abbott

Ref 07D5822

Architect 7D58-22 (07D5822) is a device classified as Class C in the EU and Class II in the US made by Abbott, registered in EUDAMED on 23 Aug 2026 (Basic UDI-DI 038074ARD0758L8) and listed in FDA GUDID since 15 Nov 2019 (UDI-DI 00380740161668), 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 Number038074ARD0758L8 Basic UDI-DI 00380740161668UDI-DIDate23 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740161668 UDI-DI Date15 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARD0758L8 registered 23 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740161668 listed 15 Nov 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740161668
  2. Registered EUDAMED 038074ARD0758L8

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  • Withdrawn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
Total amylase IVD, reagent
Device name
ARCHITECT Amylase
Model / Ref / Catalog
07D5822, 7D58-22
Primary DI / UDI-DI
00380740161668
Basic UDI-DI
038074ARD0758L8
FDA product code
JFJ
EMDN code
W01010107 Amylase - total
GMDN term
Total amylase IVD, reagent
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.1070
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
07D5822
GUDID
7D58-22
Device classEUDAMED
Class C
GUDID
Class II

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

Similar devices in this category

Other devices filed under AMYLASE - TOTAL.

Other devices from Abbott

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Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)