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Alinity 04V3810

by Abbott Ireland Diagnostics

Ref 04V3810

Alinity 04V3810 is a device classified as Class C in the EU and Class I in the US made by Abbott Ireland Diagnostics, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 038074AIV0438N4) and listed in FDA GUDID since 7 Jun 2019 (UDI-DI 00380740165505), active as of 23 Oct 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074AIV0438N4 Basic UDI-DI 00380740165505UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740165505 UDI-DI Date7 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074AIV0438N4 registered 19 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740165505 listed 7 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740165505
  2. Registered EUDAMED 038074AIV0438N4

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  • Withdrawn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
Creatine kinase myocardial isoenzyme (CKMB) IVD, control
Device name
Alinity i STAT CK-MB
Model / Ref / Catalog
04V3810
Primary DI / UDI-DI
00380740165505
Basic UDI-DI
038074AIV0438N4
FDA product code
JJY
EMDN code
W0102152004 Cardiac marker controls
GMDN term
Creatine kinase myocardial isoenzyme (CKMB) IVD, control
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class I

Device class is stated on each registry's own scale: Class C 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: Creatine kinase myocardial isoenzyme (CKMB) IVD, control

Similar devices in this category

Other devices filed under CARDIAC MARKER CONTROLS.

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

  • Contains latex
  • Contains human tissues or cells
  • 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 (14, all answered No)