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Alinity 01R3801

by Abbott Laboratories

Ref 01R3801

Alinity 01R3801 is a chemiluminescent immunoassay analyser IVD (EU IVDR Class A; FDA Class I; FDA product code JJE, Analyzer, Chemistry (Photometric, Discrete), for Clinical Use) made by Abbott Laboratories, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 038074MPR0138VG) and listed in FDA GUDID since 31 May 2018 (UDI-DI 00380740129675), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074MPR0138VG Basic UDI-DI 00380740129675UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740129675 UDI-DI Date31 May 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074MPR0138VG registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740129675 listed 31 May 2018 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00380740129675
  2. Registered EUDAMED 038074MPR0138VG

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  • Withdrawn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
Alinity
Generic name
Chemiluminescent immunoassay analyser IVD
Model / Ref / Catalog
01R3801
Primary DI / UDI-DI
00380740129675
Basic UDI-DI
038074MPR0138VG
FDA product code
JJE
EMDN code
W0201020185 Automated immunochemistry analysers - consumables
GMDN term
Chemiluminescent immunoassay analyser IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2160
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multiple clinical chemistry analyser IVD, laboratoryChemiluminescent immunoassay analyser IVD

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Properties

  • Single use
  • Professional testing
  • IVD instrument
  • Prescription use
  • Convenience kit
  • Lot / batch number
Other properties (20, all answered No)