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Three OTC COVID-19 Tests Win FDA Clearance After Template Updates

 
• By Malcolm Spicer

Access Bio’s CareStart COVID-19 Antigen test gives results within 10 minutes, Becton, Dickinson’s BD Veritor within 15 minutes and InBios International’s SCoV-2 Ag Detect within 20 minutes. All three hold emergency use authorizations.

BD's Veritor is among the tests to get an expanded indication for use this week

The US Food and Drug Administration has authorized three OTC COVID-19 antigen diagnostic tests after providing templates to help developers provide necessary data and information in support of pre-emergency use authorization submissions.

The agency’s Center for Devices and Radiological Health (CDRH) on 22 November announced emergency use authorizations (EUAs) for home-use COVID-19 antigen diagnostic tests for people 14 and older with a...

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