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SIRPA qPCR Clinical Trial Assay (CTA)

by Almac Diagnostic Services Limited

Ref SIRPA qPCR 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-SIRPAqPCRAU Basic UDI-DI D-SIRPAqPCRAUUDI-DIDate23 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  • Withdrawn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
SIRPA qPCR Clinical Trial Assay (CTA)
Model / Reference
SIRPA qPCR CTA
Primary DI / UDI-DI
D-SIRPAqPCRAU
Basic UDI-DI
B-SIRPAqPCRAU
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