C.DIFFICILE GDH DETECTION
Basic Information
- Primary DI
- 04049095140501
- Basic UDI-DI Code
- 4049095N070300000VP
- Reference
- N0703
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- R-Biopharm AG
Additional Description
For in vitro diagnostic use. The RIDAยฎQUICK Clostridium difficile GDH test is a manual immunochromatographic rapid test for the direct qualitative detection of Clostridium difficile specific glutamate dehydrogenase (GDH) from untreated human stool samples from persons with symptoms of gastroenteritis. RIDAยฎQUICK Clostridium difficile GDH is a diagnostic aid for detecting a Clostridium difficile infection in connection with other clinical and laboratory findings. Negative results do not rule out infection with Clostridium difficile and should not be used as the sole basis for diagnosis. The product is intended for professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105011801 | C.DIFFICILE GDH DETECTION |
Available In Countries
Related Devices
The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).