SINGAPORE--Agilent Technologies ($A) announced on Tuesday that its SureScan Dx microarray scanner has been approved by the China Food and Drug Administration as a medical device for use in in vitro diagnostics.
The SureScan Dx microarray scanner was first launched in 2013 and CE-marked for in vitro diagnostic use in Belgium, Denmark, Finland, France, Germany, Italy, the Netherlands, Spain, Sweden and the United Kingdom. The scanner is now approved for in vitro diagnostic use in Singapore and South Korea.
China has aggressively looked to promote local medical device equipment for its fast-growing network of public and private hospitals as concerns grow over costs and limited domestic competition to imported high-end diagnostics, making approval an important milestone. Agilent has been continuously seeking regulatory approvals in key geographies since the SureScan Dx launch in Europe and has previously expressed intentions to file for 510(k) clearance in the United States.
- see the release