Skip to content

Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse

by VitroBioChem SRL EUDAMED

Active European Union

Ref VT-CDABGDH-25Model Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5944759080VTCDABGDH25B6X8 Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

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.

Specification

EUDAMED

Model / Reference
Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse, VT-CDABGDH-25
Primary DI / UDI-DI
05944759080126
Basic UDI-DI
5944759080VTCDABGDH25B6X8
Direct Marketing DI
05944759080126
EMDN Code
W0105011803 C.difficile gdh and toxin a/b combined detection
Device Class
Class B
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
RO-MF-000010877

Other devices from VitroBioChem SRL

See all devices from VitroBioChem SRL →

Properties

  • Microbial Substances
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No