CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and medical devices, was recently granted a CE Mark certificate for the world’s first self-test for influenza A, influenza B, COVID-19 and Respiratory Syncytial Virus (RSV).

The CE Mark enables CorDx to market the test in the European Union (EU).

The Influenza A/B+COVID-19/RSV Combo Ag Test is a self-test that simultaneously detects infections of influenza A, influenza B, COVID-19, and respiratory syncytial virus (RSV) in humans. While distinct, each of these infections often manifest with similar symptoms. The test allows for detection of all four infections in a single self-administered test.

The Conformitè Europëenne (CE) Mark is the EU’s mandatory conformity marking for regulating goods sold within the European Economic Area. It indicates that CorDx’s Influenza A/B+COVID-19/RSV Combo Ag Test has been assessed and deemed to meet EU safety, health, and environmental protection requirements.

“As COVID-19 infection prevention measures relax globally, COVID and other viral infections are projected to rise. CorDx’s Influenza A/B+COVID-19/RSV Combo Ag self-test can detect all four infections in one easy-to-use test,” said Jeff Yufeng Li, CorDx’s founder & CEO. “We’re excited to introduce this important new diagnostic tool to families and healthcare providers in the EU.”

Source: Company Press Release