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Replies to post #90880 on Decision Diagnostics Corp (DECN)
Hopefull17
08/19/20 2:32 PM
#90888 RE: Johnny_C #90880
goodthings
08/19/20 2:36 PM
#90889 RE: Johnny_C #90880
(August 14 Quarterly Report) : For FDA EUA filing and the granting of a Pre-EUA by the FDA, the company first filed an application for its Professional use version of its GenViro! Covid-19 test kit on April 3. We received PEUA ( i.e. PRE-EUA) designation from the FDA on April 4. Conversations with FDA review staff began in earnest on April 14. This application was for the point of care testing of blood from human subjects. The company then filed a second EUA application with the FDA on May 1. This application was for our individual use GenViro! test kits. We received PEUA (i.e. PRE-EUA) designation from the FDA on May 2.