EntericBio® Clostridioides difficile
Basic Information
- Primary DI
- 05391513879166
- Basic UDI-DI Code
- B-05391513879166
- Reference
- EBCDA-V2
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Serosep Limited
Additional Description
For in vitro diagnostic use. The EntericBio® Clostridioides difficile (C. difficile) assay is a semi-automated, one–strip molecular diagnostic test for the direct, qualitative detection of nucleic acids from Clostridioides difficile in human stool samples. The assay is intended for use with stool samples from symptomatic individuals to aid in the diagnosis of Clostridioides difficile infection. The EntericBio® C. difficile assay can be used in combination with the optional UgenTec FastFinder software using the EntericBio® C. difficile plug-in for the analysis and results interpretation of the EntericBio® C. difficile assay PCR raw data results generated on the Roche LightCycler® 480 II PCR instrument.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105011804 | C.DIFFICILE BY NA REAGENTS |
Available In Countries
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