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Sunday, April 26, 2020 5:06:18 PM
The FDA updating its website with Healgen as one of the entities that have notified it of intent to use its serological test is what unlocked the ability for the company to begin distribution: It’s still illegal for anyone not on this list to do so, and the FDA still also specifically prohibits the use of at-home serological tests on its official guidelines
https://techcrunch.com/2020/03/27/the-fda-just-okayed-multiple-15-minute-blood-tests-to-screen-for-coronavirus-but-there-are-caveats/amp/
and this notification in the table for Healgen Scientific: EUA not required
"EUA not required: FDA allows commercial manufacturers to launch serology tests without an EUA"
https://www.360dx.com/coronavirus-test-tracker-launched-covid-19-tests
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