Basic Information
- Primary DI
- 05391513879210
- Basic UDI-DI Code
- B-05391513879210
- Reference
- EBGPDx
- 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® Dx assay is a semi-automated, three-well molecular diagnostic test for direct, qualitative detection of nucleic acids from Salmonella enterica spp., Shigella spp., Campylobacter jejuni/coli/lari, Yersinia enterocolitica spp., Vibrio cholerae/parahaemolyticus, Shiga-like toxin-producing E. coli (STEC, also known as Verotoxin-producing E. coli, VTEC) stx1/stx2, Cryptosporidium parvum/ hominis, Giardia lamblia and Entamoeba histolytica in human stool samples. The assay is intended for use with liquid/loose stool samples from symptomatic patients with suspected acute gastroenteritis of bacterial or parasitic origin. The EntericBio® Dx assay can be used in combination with the optional UgenTec FastFinder software using the EntericBio® Dx plug-in for the analysis and results interpretation of the EntericBio® Dx 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 |
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