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PNPLA3 Genotyping Clinical Trial Assay (CTA)

by Almac Diagnostic Services Limited

Ref PNPLA3 Genotyping CTA

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-PNPLA3GenotypingCTAE7 Basic UDI-DI D-PNPLA3GenotypingCTAE7UDI-DIDate25 May 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
PNPLA3 Genotyping Clinical Trial Assay (CTA)
Model / Reference
PNPLA3 Genotyping CTA
Primary DI / UDI-DI
D-PNPLA3GenotypingCTAE7
Basic UDI-DI
B-PNPLA3GenotypingCTAE7
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
XI-MF-000024200

Other devices from Almac Diagnostic Services Limited

Properties

  • Human Tissues
  • Reagent
  • Professional Testing
  • Surgical Instrument

Other properties (6)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No