Innova Medical Group Earns CE Mark for Its Rapid Antigen Self-Test for COVID-19

Pasadena, Calif.-based Innova Medical Group has received a CE mark for its Innova SARS-CoV-2 antigen rapid qualitative self-test.

The CE mark certification was received from the MED LNE Group, a notified body for in vitro diagnostics and devices. The term notified body refers to an organization designated by an EU country to assess the conformity of certain products before being placed on the market.

Innova’s rapid antigen self-test, which detects multiple proteins in the SARS-CoV-2 virus, is also approved by several other markets, including the United Kingdom, Israel and Malaysia.

Innova has supplied more than 1.5 billion lateral flow tests to customers worldwide since the start of the COVID-19 pandemic in March 2020, the company said.