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emergency use authorization approved

Eurofins Receives FDA Emergency Authorization for Over-the-Counter COVID-19 Test

March 2, 2021

Eurofins has received Emergency Use Authorization (EUA) from the FDA for the direct-to-consumer version of its EmpowerDX COVID-19 Home Collection Kit.

The at-home COVID-19 nasal polymerase chain reaction (PCR) kit can be sold directly to consumers without a prescription and can be ordered online for $99, the company said.

The test kit includes a nasal swab, a test tube and a pre-paid shipping package used to send samples for analysis. Results are posted on a secure patient portal within 48 hours, Eurofins said.

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