Skip to content

Architect 2P32-50

by Abbott Laboratories

Ref 02P3250

Architect 2P32-50 (02P3250) is a device classified as Class C in the EU and Class II in the US made by Abbott Laboratories, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 038074ARP0232NZ) and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740003821), 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 Number038074ARP0232NZ Basic UDI-DI 00380740003821UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740003821 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARP0232NZ registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740003821 listed 6 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740003821
  2. Registered EUDAMED 038074ARP0232NZ

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  • Withdrawn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
Buffered sample diluent IVD
Device name
ARCHITECT ICT (Na+, K+, Cl-) Sample Diluent
Model / Ref / Catalog
02P3250, 2P32-50
Primary DI / UDI-DI
00380740003821
Basic UDI-DI
038074ARP0232NZ
FDA product code
JGS, JJE, CEM, CGZ
EMDN code
W0101070302 Electrolyte electrode buffers and solutions
GMDN term
Buffered sample diluent IVD
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.1665, 862.2160, 862.1600, 862.1170
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
02P3250
GUDID
2P32-50
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: Buffered sample diluent IVD

Similar devices in this category

Other devices filed under ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS.

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

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