US-based Agilent Technologies has obtained approval from the China Food and Drug Administration for its SureScan Dx microarray scanner, as a medical device for in vitro diagnostic use.
Chinese University of Hong Kong associate professor Dr Richard Choy said: "Agilent’s SureScan Dx scanner offers high resolution and sensitivity as well as dynamic autofocus to correct for differences in slide thickness. This means high-quality data for analysis."
The microarray scanner features an autoloader and Agilent Microarray Scan Control software.
The system is said to measure fluorescence signals from labeled DNA and RNA targets hybridized to microarrays, to compare two DNA samples for differences.
The product already received CE mark approval for in vitro diagnostic use in Europe, as well as in South Korea and Singapore.
Agilent Technologies vice-president and Genomics general manager Peter Serpentino said: "Agilent is committed to offering quality, precision measurement equipment to clinical laboratories worldwide.
"We are pleased to introduce the SureScan Dx scanner in China for use in clinical laboratories."
Agilent provides instruments, software, services, and consumables for the laboratory workflow, in around 100 countries.