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DECN Receives Pre-EUA Acknowledgement Letter And Product Serial Number From U.S. FDA For GenViro!(TM) Covid-19 Screening Kit For Professional Use
DECN Receives Pre-EUA Acknowledgement Letter And Product Serial Number From U.S. FDA For GenViro!(TM) Covid-19 Screening Kit For Professional Use.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"COMPANY BEGINS SCALE PURCHASES OF GENVIRO!™ COMPONENTS, CREATING PACKAGING USING FDA EUA LABELING GUIDANCE, APPLICATION IN PROCESS FOR GENVIRO!™ AT-HOME SCREENING KITLOS ANGELES, CA / ACCESSWIRE / April 7, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc. the 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 received the Pre-EUA Acknowledgement letter from the U.S. FDA for device (serial number) PEUA200232, GenViro Covid-19 Screening Kit. This grant by the FDA is a major milestone in our GenViro!™ Covid-19 test kit development, now beginning its 7th week since we became aware that our manufacturer and R&D professionals were living and working at Ground Zero of the Korean Covid-19 epidemic.DECN received the Pre-EUA Acknowledgement and device serial number on Saturday, April 4, 2020. Later on this same day FDA counsel had several exchanges with FDA EUA staff. In one of those exchanges, the FDA provided Guidance for our final product testing. Keith Berman, CEO of Decision Diagnostics commented, "We filed our final application with the FDA for EUA approval on April 3, 2020, taking out all reference to our at-home use Covid-19 kit. We submitted the application late in the afternoon EDT, and incredibly we received our Pre-EUA Acknowledgement the morning of April 4, 2020, less than 24 hours later, and on the weekend. We were so stunned by the rapid acknowledgment that we waited almost two days to inquire whether the acknowledgment was what we have come to know as the "Pre-EUA." We were assured that this letter from the FDA and the device serial number assigned are exactly what we had been hoping for."As early as Saturday April 4, it was clear that the FDA review staff was aware that our methodology was different than those slower and older methods that had received FDA EUAs, or were in review. Although the testing requested will be rigorous, it appears that testing will require 30 k...