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DECN Files Finalized FDA EUA Application for Its Genviro! Covid-19 Swift Kit, Receives Notification of Acceptance From FDA After-Hours on Friday 4/3/2020
DECN Files Finalized FDA EUA Application for Its Genviro! Covid-19 Swift Kit, Receives Notification of Acceptance From FDA After-Hours on Friday 4/3/2020.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"FDA Further Assigns Genviro COVID-19 Swift Kit Application to EUA Review Group on Saturday 4/4/2020, Pre-Uea Designation Anticipated NextLOS ANGELES, CA / ACCESSWIRE / April 6, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) manufacturers and design specifiers for the GenViro! Covid-19 Swift Kit, is an 18-year old, diabetes and now disease testing bio-technology development firm, high level manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for its own proprietary regulated medical devices, announces today that the company has filed its formal and finalized Emergency Authorization for its Professional Use Covid-19 screening kit with the Emergency Authorization review group at the U.S. FDA. The application was filed on Friday 4/3/2020 late in the afternoon, acknowledged less than three hours later, and assigned for EUA review on Saturday 4/4/2020. There have already been several contacts between the FDA EUA review group and the company's FDA counsel.DECN had originally intended to submit its application for both of its Covid-19 Swift Kit products, the Professional version kit to be administered to by nurses, doctors, pharmacists and other professionals, and the at-home personal use kit we envision to be distributed by big box pharmacies, governmental agencies, home health agencies and directly by our own distributors. But because the FDA had yet to approve a kit designed for individual use, we decided to proceed first with the Pro version Swift kit and follow on as soon as possible with a separate EUA application for the at-home kit as a stand-alone application. We plan to use the same application with minor changes to reflect the individual use.Keith Berman, CEO of Decision Diagnostics commented, "In February 2020, several weeks before the Covid-19 virus began to spread through Europe and then the USA, we prayed for our Korean colleagues who had the misfortune of living and working at Ground Zero for the Covid-19 virus in the city of Daegu. Watching that terrible news gave all of us the desire to open hearts, re-examine our past products and successes, all in an effort to create a diagnostic method based our own core technology competencies even though virus detection was not in our mainstream. I have always ...