EasyScreen

Primary DI

09351179001307

Basic UDI-DI Code

B-09351179001307

Reference

PE001-MT Panel C

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Genetic Signatures Ltd

The EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001) is a rapid in vitro nucleic acid amplification assay for the qualitative detection of pathogenic enteric RNA and DNA from the stool (fresh or frozen) of patients with symptoms of gastrointestinal infection. The test, based on real-time PCR, detects 24 gastroenteritis-causing pathogens/pathotypes. The kit also includes controls to ensure the quality of the extracted nucleic acids, to detect the presence of any inhibitors, and (Panel G only) to indicate if there is any E. coli present in the sample. It is intended that the stool sample is first processed using the EasyScreen™ Sample Processing Kit (SP012). The EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001) includes all reagents required to detect the specific pathogen gene sequences using real-time PCR amplification of the nucleic acids and fluorogenic target-specific hybridisation probes for detection. It is intended to be used for diagnostic purposes, by trained personnel in clinical or hospital laboratories. Note that this product can be sold as one full PE001 product (Panels A to H) but each panel has a separate UDI-DI as customers can pick and choose the panels they use. This entry is for Panel C only. Panel C: Campylobacter spp, EC, Salmonella spp, Shigella spp/EIEC

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).