Skip to content

Architect 2P54-01

by Abbott

Part of a family of 6 devices: see the family page

Ref 02P5401

Architect 2P54-01 (02P5401) is a device classified as Class C in the EU and Class II in the US made by Abbott, registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 038074ARP0254PB) and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740003975), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ARP0254PB Basic UDI-DI 00380740003975UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740003975 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARP0254PB registered 24 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740003975 listed 6 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740003975
  2. Registered EUDAMED 038074ARP0254PB

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  • Withdrawn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
Human epididymis protein 4 (HE4) IVD, calibrator
Device name
Architect HE4
Model / Ref / Catalog
02P5401, 2P54-01
Primary DI / UDI-DI
00380740003975
Basic UDI-DI
038074ARP0254PB
FDA product code
JIT, OIU, JJX
EMDN code
W0102152205 Tumour marker standards and calibrators
GMDN term
Human epididymis protein 4 (HE4) IVD, calibrator
Device class
Class C EUDAMED
Class II GUDID
Regulation number
862.1150, 866.6010, 862.1660
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
02P5401
GUDID
2P54-01
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: Human epididymis protein 4 (HE4) IVD, calibrator

Similar devices in this category

Other devices filed under TUMOUR MARKER STANDARDS AND CALIBRATORS.

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)