www.fdanews.com/articles/206372-maxim-biomedicals-cleardetect-covid-19-test-gets-emergency-use-authorization
Maxim Biomedical’s ClearDetect COVID-19 Test Gets Emergency Use Authorization
January 31, 2022
Maxim Biomedical has received the FDA’s Emergency Use Authorization for its ClearDetect COVID-19 antigen home test.
The simple test includes three components—a swab, a test strip and a test tube pre-filled with sample buffer. This eliminates reagent measuring as well as the need to handle dropper bottles, as required with other card-based and self-test systems, the company said.
The test uses self-collected nasal swab samples and delivers results in 15 minutes that remain visible for up to 30 minutes.