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emergency use authorization approved

FDA Awards Amazon Subsidiary EUA for Direct-to-Consumer COVID-19 Test

June 11, 2021

The FDA has granted Amazon subsidiary STS Lab Holdco Emergency Use Authorization for its real-time reverse transcription polymerase chain reaction (RT-PCR) COVID-19 test, a diagnostic that can be sold directly to consumers.

The product, which is authorized for patients age 18 years and up, tests anterior nasal swab samples collected by the user at home. The test must still be shipped to an STS Lab Holdco laboratory for processing. Results are delivered to patients over the Internet and by text.

The test can be used for patients who do not have any symptoms or suspected COVID-19 infection. A nondirect-to-consumer version of the test was authorized earlier this year.

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