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APOL1 Genotyping Clinical Trial Assay (CTA)

by Almac Diagnostic Services Limited Liability Company

Ref APOL1 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-APOL1GenotypingCTABF Basic UDI-DI D-APOL1GenotypingCTABFUDI-DIDate30 Jun 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  • Withdrawn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
APOL1 Genotyping Clinical Trial Assay (CTA)
Model / Reference
APOL1 Genotyping CTA
Primary DI / UDI-DI
D-APOL1GenotypingCTABF
Basic UDI-DI
B-APOL1GenotypingCTABF
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
US-MF-000025491
Authorised representative
Almac Diagnostic Services Ireland Limited IE-AR-000024248

Other devices from Almac Diagnostic Services Limited Liability Company

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