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