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Alinity

by Abbott Ireland, Diagnostics Division 54 variants

Ref 04W2101

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number038074AIW0421MW Basic UDI-DI 00380740196530UDI-DIDate23 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
HSV-2 IgG
Model / Reference
04W2101
Primary DI / UDI-DI
00380740196530
Basic UDI-DI
038074AIW0421MW
EMDN Code
W0105080904 Other virology standards and calibrators - inf.imm.
Device Class
Class C
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000009849

Other devices from Abbott Ireland Diagnostics Division

See all devices from Abbott Ireland Diagnostics Division →

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • New Device

Other properties (5)

  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No