EasyScreen

Primary DI

09351179001161

Basic UDI-DI Code

B-09351179001161

Reference

EP005-HT

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Genetic Signatures Ltd

The Genetic Signatures’ EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005) is a rapid in vitro nucleic acid amplification assay for the qualitative detection of pathogenic gastrointestinal parasite nucleic acid from the stool of patients with signs and/or symptoms of gastroenteritis. The test, based on real-time PCR detects Cryptosporidium spp., Giardia intestinalis, Dientamoeba fragilis, Entamoeba histolytica, Blastocystis hominis, Encephalitozoon intestinalis, Enterocytozoon bieneusi, and Cyclospora cayetanensis . The kit also incorporates both an Extraction Control (EC) and an Internal Positive Control (IPC) to ensure the reliability of the extracted nucleic acid and to detect the presence of any inhibitors, respectively. It is intended that the stool is first processed using the EasyScreen™ Sample Processing Kit (SP012). The kit includes all reagents required to detect the specific protozoan gene sequences using real-time PCR amplification of the nucleic acid and fluorogenic target-specific hybridisation probes for the detection of the amplified nucleic acid.

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