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UltraGene Assay Combo 4 Screening

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

Ref 150B50Model UltraGene Assay Combo 4 Screening V2.X (50 tests) EMDN W0105070304

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05407007960576 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  • Withdrawn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 22 Oct 2026

Device Name
UltraGene Assay Combo 4 Screening V2.X
Model / Reference
UltraGene Assay Combo 4 Screening V2.X (50 tests), 150B50
Primary DI / UDI-DI
05407007960576
Basic UDI-DI
B-05407007960576
EMDN Code
W0105070304 Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex 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 81b7f790-5bdd-41c9-8cc0-1d19abfa49e0 61 fields · synced 22 Oct 2026