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abia HIV AgAb

by AB Diagnostic Systems GmbH Germany EUDAMED

Ref DK.0003.05.3Model DK.003.05.3 EMDN W0105030404

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04262351590357 Basic UDI-DIDate17 Feb 2025RegisteredStatusWithdrawn

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
DK.003.05.3, DK.0003.05.3
Primary DI / UDI-DI
04262351590357
Basic UDI-DI
B-04262351590357
EMDN Code
W0105030404 HIV multiple ag/ab combi test
Device Class
Class IVD Annex II List A
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
DE-MF-000025407

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED dcbb773f-fe1c-43a0-82a0-b118d2492ca1 61 fields · synced 24 Oct 2026