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Re: None

Tuesday, 04/28/2020 7:08:03 PM

Tuesday, April 28, 2020 7:08:03 PM

Post# of 97081
If No GenViro Device - No pre-EUA:

"A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency situation."

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/how-submit-pre-eua-vitro-diagnostics-fda