EntericBio® Viral Panel 1
Basic Information
- Primary DI
- 05391513879241
- Basic UDI-DI Code
- B-05391513879241
- Reference
- EPVP1
- 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® Viral Panel 1 assay is a semi-automated, one strip molecular diagnostic test for direct, qualitative detection of nucleic acids from Rotavirus A, Adenovirus F40/F41 and Sapovirus in human stool samples. The assay is intended for use with liquid/loose stool samples from symptomatic patients with suspected acute gastroenteritis of viral origin. The EntericBio® Viral Panel 1 assay can be used in combination with the optional UgenTec FastFinder software using the EntericBio® Viral Panel 1 plug-in for the analysis and results interpretation of the EntericBio® Viral Panel 1 assay PCR raw data results generated on the Roche LightCycler® 480 II PCR instrument.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070504 | GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).