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GenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit

by Abacus Diagnostica Oy 2 variants

Ref CDX-160-01-20Model CDX-160

Withdrawn Withdrawn in European Union.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CDX-160-01-20NA Basic UDI-DI D-CDX-160-01-20NAUDI-DIDate24 Aug 2022RegisteredStatusWithdrawn

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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Model / Reference
CDX-160, CDX-160-01-20
Primary DI / UDI-DI
D-CDX-160-01-20NA
Basic UDI-DI
B-CDX-160-01-20NA
EMDN Code
W0105070302 Other virus combinations - multiplex na reagents
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