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www.fdanews.com/articles/203889-lumiradx-gets-eua-from-fda-for-covid-19-test

LumiraDx Gets EUA from FDA for COVID-19 Test

August 9, 2021

London-based LumiraDx has received Emergency Use Authorization from the FDA for its COVID-19 antibody test.

The test, which is designed to identify recent or prior infections by measuring the body’s adaptive immune response, has been commercially available in Europe since receiving the CE mark in September 2020.

The SARS-CoV-2 Ab test runs on the company’s high-sensitivity test platform that allows for antigen and antibody testing and provides results in 11 minutes.

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