Lucira Health (Nasdaq: LHDX) today said it has asked the FDA for an emergency use authorization (EUA) for its combination COVID-19 and flu test. Emeryville, California-based Lucira said the at-home test would be available with a prescription to test for SARS-CoV-2, Influenza A and Influenza B. The Nucleic Acid Amplification Test (NAAT) platform has a […]
Lucira Health
FDA issues EUA for single-use, OTC PCR COVID-19 at-home test
Lucira Health announced today that it received FDA emergency use authorization (EUA) for over-the-counter sales of its COVID-19 test kit. Emeryville, Calif.-based Lucira’s PCR molecular test kit, the Lucira Check It kit, is designed to deliver results in 30 minutes or less at home. The authorization covers those with symptoms and those without, and the […]
FDA OKs first COVID-19 test that people can use on themselves at home
The FDA announced that it issued emergency use authorization (EUA) for the first at-home, rapid COVID-19 diagnostic test. A diagnostic designed for self-testing in the home, the Lucira COVID-19 all-in-one test kit is a molecular (real-time loop-mediated amplification reaction) single-use test designed to detect SARS-CoV-2, according to an FDA news release. Lucira’s test is authorized […]
