Life Technologies Corporation announces that its Applied Biosystems™ 3500 Dx Series Genetic Analyzers, the first CE IVD- marked capillary electrophoresis system for nucleic acid analysis** designed to comply with Directive 98/79/EC on IVD medical devices, are now available in Australia, India, New Zealand, Singapore, and Taiwan.
The 3500Dx Series Genetic Analyzers are now approved by the Singaporean and Taiwanese regulatory authorities and the current IVD policies of Australia, New Zealand, and India allow the system to enter into commercial distribution in these countries. These additional nations join 13 European countries that will now benefit from this sequencing platform, including Austria, Belgium, Finland, France, Germany, Italy, Luxembourg, the Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom.
The 3500 Dx Series Genetic Analyzers are intended for use in the analysis of human DNA or RNA for the detection of genetic changes that may lead to disease presence or susceptibility and designed with a number of enhancements for improved data quality as well as easier to use Data Collection Software. Consumables, such as POP-7™ polymer, buffers and capillary arrays utilize radio frequency identification (RFID) technology, which allows the Data Collection Software to monitor and store data for consumables, such as lot and part numbers, as well as consumables usage and other important information. This makes the system robust, easy-to-use and less prone to manual errors. Several medical institutions studying a number of critical human diseases such as cancer are currently using the 3500 Dx Series System for such analysis.
“As additional countries approve the 3500 Dx Genetic Analyzer as an IVD medical device, more important genetic sequences that aid in combating critical human diseases like cancer will be identified,” said Ben Hwang, head of the Asia Pacific region for Life Technologies. “It is evident that there is a commitment to advancing human health as countries continue to recognize the value of a system like the 3500 Dx Series. This genetic analyzer will help make the promise of personalized medicine a reality.”
The 3500 Dx Series Genetic Analyzers are part of a broader portfolio of advanced genomic technologies that are built upon Applied Biosystems legacy of providing platforms that are recognized for proven technology, reliability and performance. They provide an integrated solution that combines the instrument with Applied Biosystems reagents, consumables, software, service and support. back to top » |
clinical diagnostics
