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Re: Marty Byrd post# 30203

Wednesday, 03/25/2020 12:53:32 AM

Wednesday, March 25, 2020 12:53:32 AM

Post# of 54910
Don't need FDA approval???

https://www.biomedomics.com/latest-fda-guidance-allows-distribution-of-sars-cov-2-serology-tests-for-diagnostic-use/

March 16, the FDA updated its “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” document. https://www.fda.gov/media/135659/download

As a result, BioMedomics will be able to distribute our COVID-19 IgM-IgG Antibody Rapid Test to any licensed healthcare practitioner in the United States for diagnostic use starting on March 17, 2020.