EasyScreen

Primary DI

09351179002090

Basic UDI-DI Code

B-09351179002090

Reference

RP012-HT

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Genetic Signatures Ltd

The EasyScreen™ SARS-CoV-2 Detection Kit (RP012) is a rapid in vitro nucleic acid amplification assay for the qualitative detection of SARS-CoV-2 nucleic acid from respiratory specimens. Compatible specimens include nasal/throat or nasopharyngeal/ throat swabs (dry or in liquid media including UTM, VTM, VPM, Saline/PBS), sputum, bronchial washings, bronchoalveolar lavage, and saliva. It is intended that the sample is first processed using a compatible EasyScreen™ Sample Processing Kit. The EasyScreen™ SARS-CoV-2 Detection Kit (RP012) includes all reagents required to detect the specific SARS-CoV-2 gene sequences using real-time PCR amplification of the extracted nucleic acids and fluorogenic target-specific hybridisation probes for detection. The product is intended as an aid in the diagnosis of SARS-CoV-2 infection in patients with respiratory symptoms or those suspected of exposure to the SARS-CoV-2 virus. It is intended to be used for diagnostic purposes, by trained personnel in clinical or hospital laboratories.

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