Chinese FDA clearance for the IDS-iSYS instrument

Immunodiagnostic Systems Holdings PLC (IDS) has received notice that the China Food and Drug Administration (“CFDA”) has approved the company's IDS-iSYS automated immunoassay instrument for sale in the Chinese market.

In May 2013 IDS appointed Beijing Leadman Biochemistry Technology Co Ltd as its exclusive distributor for the IDS-iSYS instrument and assays in the People's Republic of China. Since May 2013 IDS have been working closely with Leadman on CFDA clearance for the IDS-iSYS instrument as well as a number of Leadman and IDS automated immunoassays for use on the IDS-iSYS.

Patrik Dahlen CEO of IDS commented, "We are delighted to receive the CFDA clearance of the IDS-iSYS instrument within our projected timeframe. This approval is a key milestone in allowing us to access the large and fast growing Chinese diagnostic market. The next step is to gain CFDA approval for the automated assays for use on the IDS-iSYS and we continue to work closely with our Chinese partner, Leadman, in order to achieve this.”