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FDA Grants EUA For OTC Sale Of LUCIRA CHECK IT COVID-19 At-Home Test Kit - Quick Facts

Medical technology company Lucira Health, Inc. (LHDX) announced Monday that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for over the counter (OTC) sale of the LUCIRA CHECK IT COVID-19 At-Home test kit that delivers PCR quality molecular accuracy in 30 minutes or less at home.

The Lucira CHECK IT Test Kit fits in the palm of a hand, extracts genetic material from the virus and amplifies it similar to PCR lab tests.

This primarily U.S. designed and manufactured product was the first FDA authorized, prescription, molecular diagnostic test for COVID-19 that could be self-administered by patients at home or used in a physician's office.

It is authorized and available for individuals with or without symptoms and can be ordered from lucirahealth.com for $55. This OTC clearance dramatically expands the availability of this highly accurate test.

Each single-use test kit contains everything needed to conduct one COVID-19 test. It can detect a positive result in as few as 11 minutes or confirm a negative result within 30 minutes.

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