SD Biosensor’s COVID-19 At-Home Test Gets FDA’s Emergency Use Authorization

December 31, 2021

South Korea-based SD Biosensor’s COVID-19 At-Home Test has received Emergency Use Authorization from the FDA.

The over-the-counter antigen test is authorized for use with self-collected anterior nasal swab samples from people age 14 years and up with symptoms of COVID-19 within the first six days of symptom onset, or samples collected by adults from children age two to 13.

It can also be used on asymptomatic individuals when tested twice over three days with at least 24 hours, and no more than 48 hours, between tests.

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