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Architect 1E49-21

by Abbott

Ref 01E4921

Architect 1E49-21 (01E4921) is a device classified as Class C in the EU and Class II in the US made by Abbott, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 038074ARE0149KL) and listed in FDA GUDID since 15 Aug 2019 (UDI-DI 00380740163372), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ARE0149KL Basic UDI-DI 00380740163372UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740163372 UDI-DI Date15 Aug 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARE0149KL registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740163372 listed 15 Aug 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740163372
  2. Registered EUDAMED 038074ARE0149KL

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  • Withdrawn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
Ion selective electrode (ISE) reference solution IVD, reagent
Device name
ARCHITECT ICT Reference Solution
Model / Ref / Catalog
01E4921, 1E49-21
Primary DI / UDI-DI
00380740163372
Basic UDI-DI
038074ARE0149KL
FDA product code
CGZ, JJE, JGS, CEM
EMDN code
W0101070399 Reference materials and buffers (electrolytes) - other
GMDN term
Ion selective electrode (ISE) reference solution IVD, reagent
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.1170, 862.2160, 862.1665, 862.1600
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
01E4921
GUDID
1E49-21
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: Ion selective electrode (ISE) reference solution IVD, reagent

Similar devices in this category

Other devices filed under REFERENCE MATERIAL AND BUFFERS (ELECTROLYTES).

Other devices from Abbott

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Properties

  • Reagent
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)