EasyScreen

Primary DI

09351179001055

Basic UDI-DI Code

B-09351179001055

Reference

EP001-HT

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Genetic Signatures Ltd

The Genetic Signatures’ EasyScreen™ Enteric Protozoan Detection Kit (EP001) is an 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 species, Giardia intestinalis, Dientamoeba fragilis, Entamoeba histolytica and Blastocystis hominis in extracted stool samples. Each reaction also incorporates both an Extraction Control (EC)and an Internal Positive Control (IPC) to determine the reliability of the extracted nucleic acid and to detect the presence of any inhibitors, respectively. The stool sample should first be prepared via Genetic Signatures’ EasyScreen™ Sample Processing Kit (SP012). The EasyScreen™ Enteric Protozoan Detection Kit (EP001) 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. 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 a pathology lab or similar, by trained personnel

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