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Alinity 09P6324

by Abbott Ireland

Ref 09P6324

Alinity 09P6324 is a device classified as Class B in the EU and Class II in the US made by Abbott Ireland, registered in EUDAMED on 23 Aug 2026 (Basic UDI-DI 038074LFD0012KC) and listed in FDA GUDID since 29 Apr 2021 (UDI-DI 00380740169916), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074LFD0012KC Basic UDI-DI 00380740169916UDI-DIDate23 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740169916 UDI-DI Date29 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074LFD0012KC registered 23 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740169916 listed 29 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740169916
  2. Registered EUDAMED 038074LFD0012KC

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  • Withdrawn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
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Device name
Alinity c Immunoglobulin M Reagent Kit
Model / Ref / Catalog
09P6324
Primary DI / UDI-DI
00380740169916
Basic UDI-DI
038074LFD0012KC
FDA product code
DFT
EMDN code
W0102010107 Immunoglobulin m
GMDN term
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Device class
Class B EUDAMED
Class II GUDID
Regulation number
866.5550
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class II

Device class is stated on each registry's own scale: Class B 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 immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Similar devices in this category

Other devices filed under IMMUNOGLOBULIN M.

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)