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Alinity-Architect 01P0603

by Abbott Laboratories

Ref 01P0603

Alinity-Architect 01P0603 is a device classified as IVD General (EU), Class II (US) made by Abbott Laboratories, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-00380740168209) and listed in FDA GUDID since 14 Jun 2019 (UDI-DI 00380740168209), 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-00380740168209 Basic UDI-DI 00380740168209UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740168209 UDI-DI Date14 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740168209 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740168209 listed 14 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740168209
  2. Registered EUDAMED B-00380740168209

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  • Withdrawn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
Alinity EUDAMED
Alinity-Architect GUDID
Generic name
Assay container IVD, single-use
Device name
Transplant Pre-Treatment Tubes
Model / Ref / Catalog
01P0603
Primary DI / UDI-DI
00380740168209
Basic UDI-DI
B-00380740168209
FDA product code
MLM, MKW, NRP
EMDN code
W0102080699 Immunosuppressant tdm - other
GMDN term
Assay container IVD, single-use
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1678, 862.1235, 862.3840
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II
Supplied sterileEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 00380740168209: EUDAMED states No, FDA GUDID states Yes.

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: Assay container IVD, single-use

Similar devices in this category

Other devices filed under IMMUNOSUPPRESSANT TDM.

Other devices from Abbott Laboratories

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Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Single use
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)