Basic Information
- Primary DI
- 05391513879272
- Basic UDI-DI Code
- B-05391513879272
- Reference
- EBCPE
- 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® CPE assay is a semi-automated, molecular diagnostic test for the direct, qualitative detection of carbapenemase genes in Enterobacteriaceae from human stool specimens. The assay is intended for use with stool samples or rectal swabs (in liquid medium) as well as bacterial isolates cultured from clinical specimens to aid in the detection, identification and infection control of carbapenemase-producing Enterobacteriaceae that colonise patients in healthcare settings. The EntericBio® CPE assay can be used in combination with the optional UgenTec FastFinder software using the EntericBio® CPE plug-in for the analysis and results interpretation of the EntericBio® CPE assay PCR raw data results generated on the Roche LightCycler® 480 II PCR instrument.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0104080606 | NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE |
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