EasyScreen

Primary DI

09351179002021

Basic UDI-DI Code

B-09351179002021

Reference

RP007-HT

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Genetic Signatures Ltd

The EasyScreen™ Respiratory Pathogen Detection Kit (RP007) is a rapid in vitro nucleic acid amplification assay for the qualitative detection of respiratory pathogen nucleic acid from respiratory specimens. Compatible specimens include respiratory swabs (dry or in VTM, UTM, PBS), sputum, and bronchoalveolar lavage (BAL). The test, based on real-time PCR, enables detection of multiple respiratory pathogen targets, as outlined in Table 1. The kit also includes a Lysed Extraction Process Control (LEPC) in order to determine the reliability of the extracted nucleic acids, validate the reverse transcription process and indicate the presence of any inhibitors after extraction from primary samples. As well as an endogenous Extraction Control (EC) to monitor the presence and quality of the extracted nucleic acids. It is intended that the sample is first processed using a compatible EasyScreen™ Sample Processing Kit. The EasyScreen™ Respiratory Pathogen Detection Kit (RP007) includes all reagents required to detect the specific viral and bacterial gene sequences using real-time PCR amplification of the nucleic acids and fluorogenic target-specific hybridisation probes for detection of the amplified nucleic acid. The product is semi-automated and intended as an aid in the diagnosis of respiratory infections. It is intended to be used for diagnostic purposes, by trained personnel in clinical, pathology, or research laboratories.

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