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Alinity 08P6101

by Abbott

Ref 08P6101

Alinity 08P6101 is a device classified as IVD General (EU), Class II (US) made by Abbott, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00380740135539) and listed in FDA GUDID since 30 Jul 2018 (UDI-DI 00380740135539), 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-00380740135539 Basic UDI-DI 00380740135539UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740135539 UDI-DI Date30 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740135539 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740135539 listed 30 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740135539
  2. Registered EUDAMED B-00380740135539

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  • Withdrawn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
Total bilirubin IVD, calibrator
Device name
Bilirubin Cal
Model / Ref / Catalog
08P6101
Primary DI / UDI-DI
00380740135539
Basic UDI-DI
B-00380740135539
FDA product code
JIX
EMDN code
W0101050399 Calibrators and standards (clinical chemistry) - other
GMDN term
Total bilirubin 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: Total bilirubin IVD, calibrator

Similar devices in this category

Other devices filed under CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER.

Other devices from Abbott

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Properties

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