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Wednesday, April 15, 2020 9:14:33 AM
The commercial manufacturers and laboratories listed below have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019. The FDA has not reviewed the validation of tests offered by these developers, who may not be pursuing EUAs, and is including this list here to provide transparency regarding the notifications submitted to FDA.
Laboratory Notifications:
Arrayit Corporation
Beaumont Health
Boston Heart Diagnostic
etc.
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2
Now if they can finally publish fins we might come back from our grey grave.
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