www.fdanews.com/articles/197073-quidel-gets-emergency-clearance-for-covid-19-diagnostic
Quidel Gets Emergency Clearance for COVID-19 Diagnostic
May 12, 2020
Quidel has received an Emergency Use Authorization from the FDA for its Sofia 2 rapid antigen COVID-19 diagnostic test.
The assay is designed for use with the company’s Sofia 2 fluorescent immunoassay analyzer for rapidly detecting the coronavirus in nasal or nasopharyngeal samples.
The immunoassay analyzer delivers automated test results in 15 minutes.