A COVID-19 diagnostic designed for use on a system that can process up to 1,000 tests in 24 hours will receive advanced development support from an HHS BARDA grant.
Read MoreThe product is expected to be CE marked and submitted to the FDA by the end of March 2020 to consider for emergency use authorization.
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FDA has exercised enforcement discretion to give the New York State Department of Health permission to authorize lab testing for COVID-19.
Read MoreThe test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing.
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Bio-Rad is providing the SARS CoV-2 Standard to help labs validate their COVID-19 assay results and accelerate access to testing.
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