US FDA Grants Three OTC Covid-19 Test EUAs Following Template Updates To Spur Development

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.

• Source: Alamy

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 on Nov. 22 announced emergency use authorizations for home-use COVID-19 antigen diagnostic...

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