C.DIFFICILE BY NA REAGENTS
Basic Information
- Primary DI
- 04049095210068
- Basic UDI-DI Code
- 4049095UN08350000SS
- Reference
- UN0835
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- R-Biopharm AG
Additional Description
For in vitro diagnostic use. The RIDAยฎUNITY C. difficile test, performed automatically or manually, is a multiplex real-time PCR for the direct qualitative detection of Clostridioides difficile DNA and Clostridioides difficile-Toxin A/B DNA in untreated stool samples from persons with signs and symptoms of acute gastroenteritis. The RIDAยฎUNITY C. difficile test is intended to support the differential diagnosis of Clostridioides difficile infections in patients with symptoms of gastroenteritis in connection with other clinical and laboratory findings. Negative results do not rule out Clostridioides difficile infection and should not be used as the sole basis for diagnosis. The product is intended for professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105011804 | C.DIFFICILE BY NA REAGENTS |
Available In Countries
Similar Devices
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