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Alinity 09P4140

by Abbott Ireland Diagnostics

Ref 09P4140

Alinity 09P4140 is a device classified as IVD General (EU), Class II (US) made by Abbott Ireland Diagnostics, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00380740154233) and listed in FDA GUDID since 5 May 2020 (UDI-DI 00380740154233), 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-00380740154233 Basic UDI-DI 00380740154233UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740154233 UDI-DI Date5 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740154233 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00380740154233 listed 5 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740154233
  2. Registered EUDAMED B-00380740154233

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  • Withdrawn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
Generic name
Rapamycin (sirolimus) therapeutic drug monitoring IVD, reagent
Model / Ref / Catalog
09P4140
Description
Alinity i Sirolimus Whole Blood Precipitation Reagent 1 Tests
Primary DI / UDI-DI
00380740154233
Basic UDI-DI
B-00380740154233
FDA product code
NRP
EMDN code
W0102080604 Rapamycin (sirolimus)
GMDN term
Rapamycin (sirolimus) therapeutic drug monitoring IVD, reagent
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
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 · 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: Rapamycin (sirolimus) therapeutic drug monitoring IVD, reagent

Similar devices in this category

Other devices filed under IMMUNOSUPPRESSANT TDM.

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Properties

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