EasyScreen

Primary DI

09351179004056

Basic UDI-DI Code

B-09351179004056

Reference

PC-RES-007

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Genetic Signatures Ltd

The EasyScreen™ Respiratory PCR Positive Control (PC-RES-007) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the viral, bacterial and fungal targets in the EasyScreen™ Respiratory Pathogen Detection Kit range. The Positive Control does not require processing and is added directly to the PCR Reaction Mix when a positive signal in all detection channels is required for quality control purposes. This Positive Control provides evidence that all PCR targets are being detected as expected and does not interfere with results from clinical specimens. This Positive Control is an in vitro diagnostic (IVD) to be used in clinical, hospital or pathology laboratories, by trained personnel.

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