21st Aug 2014 09:42
LONDON (Alliance News) - Immunodiagnostic Systems Holdings PLC said Thursday that it had received clearance from the China Food and Drug Administration for its IDS-iSYS automated immunoassay instrument.
The company appointed Leadman Biochemistry Technology Co Ltd as the exclusive distributor for its IDS-iSYS instrument and assays in China in May 2013. Since then, it has been working with Leadman to secure clearance for the instrument as well as a number of assays to be used with it.
Immunodiagnostic expects to see approval for the first 20 assays for use on the instrument by the fourth quarter of 2014.
"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," said Chief Executive Patrik Dahlen in a statement.
Shares in Immunodiagnostic were trading down 1.1% at 470.00 pence Thursday morning.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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