FDA clears text

FDA Clears Lucira Health’s COVID-19 Diagnostic for Over-the-Counter Use

April 13, 2021

Lucira Health’s Lucira Check It test kit has received Emergency Use Authorization from the FDA, allowing the COVID-19 test to be purchased over the counter.

The test delivers polymerase chain reaction-level accuracy at home in 30 minutes or less, the company claimed. It can detect a positive result in as few as 11 minutes and can confirm a negative result within a half hour.

Lucira said the test was the first prescription molecular diagnostic COVID-19 test to receive FDA authorization. The over-the-counter test can be purchased online from the company for $55.

The new clearance “dramatically expands the availability of this highly accurate test,” the company said.

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