Saint George, UT
March 18th, 2013
DXNA, LLC is very pleased to announce that it has achieved ISO 13485:2003 recertification in March 2013. DXNA, LLC was originally issued an ISO 13485:2003 certificate in April of 2010, which was a significant milestone for the start-up company. DxNA was awarded the recertification by BSI Group America, Inc for it continued compliance with the guidelines set by the International Organization of Standardization. ISO13485Certificate_2013.pdf
This ISO certification supports DXNA’s corporate objectives, while reinforcing a culture of operating within the spirit of its Quality Management System as stated in the quality policy statement that says that “ In all of our business activities quality will be delivered the first time, on time, every time.”This recertification confirms that DxNA’s team is making the effort to comply with the policy and is succeeding at doing so.
“For every business in this highly regulated industry it is important to establish and comply with the spirit of a Quality Management System, regardless of their size.Even though DxNA is pre-regulatory, our attitude is that we will make every effort to comply with quality standards and quality regulations,“ says David Taus, CEO. He goes on, “We are both proud and excited about our ISO 13485 recertification, which is essential for participating in the world’s economy. We are continually seeking ways to ensure our partners and customers worldwide we hold ourselves to the highest standards in the design, manufacturing, and distribution of our products to assure they receive the highest quality products and consistent service.”
DxNA is a privately held company located in St. George Utah. It is a molecular diagnostics company that develops and distributes portable, fully-integrated systems and tests for infectious disease in the medical, agricultural, food safety, and biosecurity markets. The Company’s systems and technologies enable rapid and precise molecular testing to take place on-site by allowing for otherwise complex, manual, laboratory procedures to be performed almost anywhere.
DxNA’s patented GeneSTAT® portable Real Time PCR molecular diagnostic testing system allows individuals with minimal training to conduct accurate real-time diagnostic testing in virtually any location including laboratories, clinics, physician offices, emergency rooms or field settings.Designed with economy in mind, GeneSTAT is inherently less costly than the real time PCR systems typical of clinical laboratories.