DNA Genotek Inc. Submits Filing for 510(k) Clearance
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DNA Genotek Inc. Submits Filing for 510(k) Clearance

Ottawa : Canada | Mar 15, 2011 at 3:48 AM PDT
Source: PRWeb
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Oragene/saliva DNA collection kit We believe that the successful completion of this 510(k) clearance will facilitate broad use of OrageneDx in molecular diagnostics. March 15, 2011 DNA Genotek Inc. a leading provider of products for biological sample collection, stabilization and preparation, announced today that it has completed filing a 510(k) pre market submission to the U.S. Food and Drug Administration for its Oragene®Dx family of products. Oragene products are recognized for enabling non-invasive and reliable collection of DNA from saliva samples and for isolating and stabilizing DNA for transport and storage. OrageneDx is the newest addition to the family of products and will be commercially available upon clearance by the FDA. Ian Curry, president and CEO of DNA Genotek Inc. said We have filed for 510(k) clearance status on our OrageneDx products to reinforce the proven performance, safety and efficacy we have already demonstrated with thousands of customers in more than 100 countries around the world. We feel it is imperative for labs and molecular test manufacturers worldwide to have access to the highest quality, proven, non-invasive collection methods to enable genetic testing. Added Curry, We believe that the successful completion of this 510(k) clearance will facilitate broad use of OrageneDx in molecular diagnostics. We continue to see an expanding set of important, valuable applications for clinical diagnostics and personalized medicine . We have filed our submission and now the final decision is with the U.S...About DNA Genotek: DNA Genotek focuses on providing high-quality biological sample collection products. The company's Oragene family of products provides the best way to collect and preserve large amounts of DNA or RNA from saliva. The company also offers a family of products for collecting DNA from animals and livestock. The reliability and ease-of-use of the company's products have resulted in rapid adoption at top-tier health research institutions globally, including Harvard, Stanford, Cambridge, and Johns Hopkins. DNA Genotek markets its products worldwide and has established a global customer base in over 100 countries.

 
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