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GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit

by Abacus Diagnostica Oy 3 variants

Ref CDX-140-01-20, CDX-150-01-20Model CDX-140, CDX-150

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CDX-140Q9 Basic UDI-DI Date24 Aug 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  • Withdrawn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

Trade Name
GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit
GenomEra® SARS-CoV-2 2.0 Assay Kit
Model / Reference
CDX-140, CDX-140-01-20, CDX-150, CDX-150-01-20
Primary DI / UDI-DI
D-CDX-140Q9, D-CDX-150-01-20MP
Basic UDI-DI
B-CDX-140Q9, B-CDX-150-01-20MP
EMDN Code
W0105040519
Device Class
Class IVD General
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000024114

Properties

  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (7)

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