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Home » Eurofins gains EUA for young children’s COVID test

Eurofins gains EUA for young children’s COVID test

May 21, 2021 By Sean Whooley

EurofinsEurofins announced today that it received FDA emergency use authorization (EUA) for its at-home COVID-19 testing kit for children 3 years of age and older.

Luxembourg-based Eurofins’ Clinical Enterprise subsidiary became the first to receive EUA for an at-home nasal PCR test for young children with the empowerDX kit, according to a news release. In March, Eurofins launched the direct-to-consumer, FDA-authorized at-home COVID-19 test kit for consumers 18 years of age and older.

The test kit is available through Eurofins’ Clinical Enterprise/empowerDX subsidiary and can be ordered online for $99, while kits are also available for purchase on Amazon, at RiteAid and through Uber’s on-demand delivery service.

Eurofins’ kit includes step-by-step instructions for the user, a shallow nasal swab, a test tube and a pre-paid FedEx package for the simple return of samples, for which customers will receive results through a secure patient portal within 48 hours.

Filed Under: Diagnostics, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: coronavirus, COVID-19, Eurofins, FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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