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Marty Byrd

03/25/20 12:53 AM

#30204 RE: Marty Byrd #30203

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.