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STANDARD™ Q HCV Ab Test

by SD Biosensor Inc. 2 variants

Ref QHCV01B/ 09HCV40DModel QHCV01B

Active European Union

CE IVDR

Valid until

2 Feb 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

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/IVDR Number88001117IPDA01QA07Z3 Basic UDI-DI Date2 Oct 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 075369 0073 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    29 Sep 2026
    Expires
    2 Feb 2031
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
QHCV01B, QHCV01B/ 09HCV40D
Primary DI / UDI-DI
08800111723889, 08800111723919, 08800111723902, 08800111723896
Basic UDI-DI
88001117IPDA01QA07Z3
EMDN Code
W0105090202 Hcv antibody -rt & poc
Device Class
Class D
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000009168
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Sd Biosensor, Inc.

See all devices from Sd Biosensor, Inc. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No