NEW YORK (GenomeWeb News) – Health Canada has approved Life Technologies' 3500 series Sanger sequencers for diagnostic use, the firm announced today.
The company's Applied Biosystems 3500xL Dx Genetic Analyzer is an automated 24 capillary-based Sanger sequencer and its 3500 Dx is an eight capillary instrument.
The company received 510(k) clearance from the US Food and Drug Administration for the instruments along with its SeCore HLA typing kits in February.
"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," Ronnie Andrews, president of medical sciences at Life Technologies, said in a statement.
Life Tech's 7500 Fast Dx and the QuantStudio Dx real-time PCR instruments are also approved for diagnostic use in Canada as Class I devices.