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OraQuick HCV Rapid Antibody Test

by OraSure Technologies, Inc. United States EUDAMED

Ref 3001-2141 EMDN W0105090202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00608337000566 Basic UDI-DIDate9 Jun 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  • Withdrawn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
OraQuick HCV Rapid Antibody Test, Pouched Device
Model / Reference
3001-2141
Primary DI / UDI-DI
00608337000566
Basic UDI-DI
B-00608337000566
EMDN Code
W0105090202 Hcv antibody -rt & poc
Device Class
Class IVD Annex II List A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000009941
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from OraSure Technologies, Inc.

See all devices from OraSure Technologies, Inc. →

Properties & raw data

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

Sources (1)

  • EUDAMED 86eb86c3-6a41-4a2d-8334-41c59cf8936c 61 fields · synced 24 Oct 2026