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UltraGene Assay SARS-CoV-2 Universalis

by Advanced Biological Laboratories (Abl) S.A. Luxembourg EUDAMED

Ref 169B1000Model UltraGene Assay SARS-CoV-2 Universalis V2.X (1000 tests) EMDN W0105041106

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05407007960439 Basic UDI-DIDate14 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
UltraGene Assay SARS-CoV-2 Universalis V2.X
Model / Reference
UltraGene Assay SARS-CoV-2 Universalis V2.X (1000 tests), 169B1000
Primary DI / UDI-DI
05407007960439
Basic UDI-DI
B-05407007960439
EMDN Code
W0105041106 Coronavirus - na reagents
Device Class
Class IVD General
Market of Registration
Luxembourg

Manufacturer details

EUDAMED SRN
LU-MF-000003752

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Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 4a920009-49bb-466c-ab4d-4b827d10651b 61 fields · synced 24 Oct 2026