EasyScreen

Primary DI

09351179001024

Basic UDI-DI Code

B-09351179001024

Reference

EB001-HT

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Genetic Signatures Ltd

The EasyScreen™ Enteric Bacteria Detection Kit (EB001) is a rapid in vitro nucleic acid amplification assay for the qualitative detection of bacterial DNA from stool of patients with diarrhoea or as a confirmatory test from cultured bacteria. The test, based on real-time PCR detects (i) Salmonella spp., (ii) Campylobacter spp., (iii) Shigella spp. /Enteroinvasive Escherichia Coli (EIEC), (iv) Yersinia enterocolitica, (v) toxigenic Clostridoides difficile and (vi) Listeria monocytogenes. The kit also includes both an Extraction Control and an Internal Positive Control for each sample to ensure the quality of the extracted DNA and to detect the presence of any inhibitors, respectively. The stool or culture sample must first be processed using a compatible EasyScreen™ Sample Processing Kit. The EasyScreen™ Enteric Bacteria Detection Kit (EB001) includes all reagents required to detect the specific bacterial gene sequences using real-time polymerase chain amplification of the DNA and fluorogenic target-specific hybridisation probes for the detection of the amplified DNA. The device is intended as an aid in the diagnosis of gastrointestinal illness. It is an in vitro diagnostic (IVD) intended to be used in pathology labs, or similar, by trained personnel

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