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news.Life Technologies' applied biosystems 3500xL Dx genetic analyzer has been approved by China's State Food and Drug Administration (SFDA) for clinical diagnostic use in the country.
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The 3500xL Dx is an automated 24 capillary-based Sanger Sequencer designed to deliver high quality performance, higher throughput and increased productivity for clinical laboratories around the world.
The company’s genetic analyzer 3500 Dx, which was approved by SFDA for IVD use in 2011 in China, and the 3500xL Dx provide the flexibility that hospitals of all sizes need to meet their throughput demands.
Life Technologies Medical Sciences president Ronnie Andrews said, "The current approval of the 3500xL Dx by SFDA emphasizes Life Technologies’ success in pursuing regulatory pathways for our diagnostics laboratory instruments as well as our vision to becoming a global leader in the molecular diagnostics industry."
The company said it has also launched 10 assays from its joint venture with Daan Gene among which nine of them are research based kits and the other one is used in Trisomy 21 prenatal screening for Down syndrome.