Skip to content

Alinity 09P4201

by Abbott Ireland Diagnostics

Ref 09P4201

Alinity 09P4201 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-00380740151010) and listed in FDA GUDID since 2 Jan 2020 (UDI-DI 00380740151010), 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-00380740151010 Basic UDI-DI 00380740151010UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740151010 UDI-DI Date2 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740151010 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00380740151010 listed 2 Jan 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740151010
  2. Registered EUDAMED B-00380740151010

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  • Withdrawn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
Tacrolimus therapeutic drug monitoring IVD, calibrator
Device name
Tacrolimus
Model / Ref / Catalog
09P4201
Primary DI / UDI-DI
00380740151010
Basic UDI-DI
B-00380740151010
FDA product code
JIT
EMDN code
W0102152201 Tdm/drug standards and calibrators
GMDN term
Tacrolimus therapeutic drug monitoring IVD, calibrator
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150
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: Tacrolimus therapeutic drug monitoring IVD, calibrator

Similar devices in this category

Other devices filed under TDM/DRUG STANDARDS AND CALIBRATORS.

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)