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OraQuick HCV Rapid Antibody Test

by OraSure Technologies, Inc. 5 variants

Ref 1001-0370

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn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Withdrawn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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-1001-0370BY Basic UDI-DI D-1001-0370BYUDI-DIDate21 Jul 2026RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
OraQuick HCV Rapid Antibody Test, 25 Count, Korea
Model / Reference
1001-0370
Primary DI / UDI-DI
D-1001-0370BY
Basic UDI-DI
B-1001-0370BY
EMDN Code
W0105090202 Hcv antibody -rt & poc
Device Class
Class IVD Annex II List A

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

  • 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