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Alinity 08P6001

by Abbott

Ref 08P6001

Alinity 08P6001 is an in vitro diagnostic device (EU IVDD general IVD; FDA Class II; FDA product code JIX, Calibrator, multi-analyte mixture; EMDN category calibrators multicomponent (cc)) made by Abbott, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00380740121969) and listed in FDA GUDID since 6 Jun 2018 (UDI-DI 00380740121969), 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-00380740121969 Basic UDI-DI 00380740121969UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740121969 UDI-DI Date6 Jun 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740121969 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740121969 listed 6 Jun 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740121969
  2. Registered EUDAMED B-00380740121969

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  • Withdrawn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
Multiple-type clinical chemistry analyte profile IVD, calibrator
Model / Ref / Catalog
08P6001
Primary DI / UDI-DI
00380740121969
Basic UDI-DI
B-00380740121969
FDA product code
JIX
EMDN code
W0101050301 Calibrators multicomponent (cc)
GMDN term
Multiple-type clinical chemistry analyte profile 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
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: Multiple-type clinical chemistry analyte profile IVD, calibrator

Similar devices in this category

Other devices filed under CALIBRATORS MULTICOMPONENT (CC).

Other devices from Abbott

See all devices from Abbott →

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)