Health Canada has approved Life Technologies' applied biosystems 3500 Dx /3500 xL Dx Genetic Analyzers CS2 for diagnostic use.
The 3500xL Dx is an automated 24 capillary Sanger Sequencer instrument while the 3500 Dx is an eight capillary instrument.
The 3500 Dx Series Genetic Analyzers are expected to offer high quality performance, higher throughput and increased productivity for clinical laboratories.
The 3500xL Dx and 3500 Dx instruments also offer a wide range of research applications, including de novo sequencing and mutational profiling, according to the company.
Life Technologies Medical Sciences president Ronnie Andrews said, "The current approval of the 3500 Dx Series Genetic Analyzers by Health Canada 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 3500 Dx/3500xL Dx Genetic Analyzers CS2 Series had received the US Food and Drug Administration (FDA) 510(k) clearance for use with the Life’s SeCore HLA typing kits in February 2013.