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Alinity 06S6101

by Abbott Ireland Diagnostics

Ref 06S6101

Alinity 06S6101 is a device classified as IVD General (EU), Not classified (US) made by Abbott Ireland Diagnostics, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00380740193805) and listed in FDA GUDID since 6 Apr 2021 (UDI-DI 00380740193805), 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-00380740193805 Basic UDI-DI 00380740193805UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740193805 UDI-DI Date6 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00380740193805 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740193805 listed 6 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740193805
  2. Registered EUDAMED B-00380740193805

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  • Withdrawn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
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
Model / Ref / Catalog
06S6101
Primary DI / UDI-DI
00380740193805
Basic UDI-DI
B-00380740193805
FDA product code
QKO
EMDN code
W0105080904 Other virology standards and calibrators - inf.imm.
GMDN term
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
Device class
Class IVD General EUDAMED
N GUDID
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
N

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), N in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

Similar devices in this category

Other devices filed under STANDARDS AND CALIBRATORS - INFECT. IMMUNOLOGY/NAT.

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

  • 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 (15, all answered No)