EasyScreen

Primary DI

09351179001864

Basic UDI-DI Code

B-09351179001864

Reference

EP002-HT

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Genetic Signatures Ltd

The EasyScreen™ Enteric Protozoan Core Kit (EP002) is a rapid in vitro nucleic acid amplification assay for the qualitative detection of protozoan DNA from stool. It comprises a simple and rapid molecular method for the detection of Cryptosporidium spp., Giardia intestinalis, and Entamoeba histolytica in extracted stool samples. The kit also incorporates an Extraction Control (EC) to determine the reliability of the extracted nucleic acid and to detect the presence of any inhibitors. The stool sample should first be prepared via EasyScreen™ Sample Processing Kit (SP012). The EasyScreen™ Enteric Protozoan Core Kit (EP002) includes all reagents required to detect the specific protozoan gene sequences using real-time PCR amplification of the extracted nucleic acids and fluorogenic target-specific hybridisation probes for detection. It is an in vitro diagnostic (IVD) intended as an aid in the diagnosis of gastrointestinal illness. It is an IVD intended to be used by trained personnel in clinical, pathology or hospital laboratories.

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