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Architect 5P03-27

by Abbott

Ref 05P0327Model 5P03-27

Architect 5P03-27 (05P0327) is a galectin-3 IVD (EU IVDD general IVD; FDA Class II) made by Abbott, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00380740096618) and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740096618), 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-00380740096618 Basic UDI-DI 00380740096618UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740096618 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740096618 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740096618 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740096618
  2. Registered EUDAMED B-00380740096618

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  • Withdrawn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
Galectin-3 IVD, kit, chemiluminescent immunoassay
Device name
Galectin-3
Model / Ref / Catalog
5P03-27, 05P0327
Primary DI / UDI-DI
00380740096618
Basic UDI-DI
B-00380740096618
FDA product code
JIT, JJX, OSX
EMDN code
W01021313 Galectin-3
GMDN term
Galectin-3 IVD, kit, chemiluminescent immunoassay
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150, 862.1660, 862.1117
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: Galectin-3 IVD, kit, chemiluminescent immunoassay

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Other devices filed under CARDIAC MARKERS.

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Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)