www.fdanews.com/articles/207083-biolytical-laboratories-gets-ce-mark-for-its-istatis-covid-19-antigen-home-test
BioLytical Laboratories Gets CE Mark for its iStatis COVID-19 Antigen Home Test
March 23, 2022
Canada-based BioLytical Laboratories has received a CE mark for its iStatis COVID-19 antigen home test.
The COVID-19 test is part of a new test platform that uses the company’s proprietary lateral flow immunoassay technology. The company claims that the COVID-19 test demonstrated 100 percent accuracy in clinical studies.
BioLytical Laboratories has begun marketing its iStatis testing platform in European countries based on the CE mark certification for the antigen test.