December 2 Update: Updated Information on Testing for SARS-CoV-2 Thank you for your interest in the development of diagnostics for SARS-CoV-2. The FDA recently UPDATED the answer to the following questions: Serology/Antibody Tests - If antibody tests are not used for diagnosis or exclusionof COVID-19 infection, what is their purpose?
COVID-19 Testing Supplies - I am considering offering clinical testing using the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. What are the considerations I should be aware of regarding extraction platforms ?
Questions? Email CDRH-EUA-Templates@fda.hhs.gov |
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