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.”
From its headquarters in Atlanta, Ga., CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world. Through its product realization partnerships with leading pharmaceutical companies, CorDx develops, manufactures, and distributes diagnostics and related tools that empower users to monitor and improve their health. Its proprietary line of diagnostics solutions is recognized by families and medical professionals for their reliability, affordability, and rapid results.
CorDx is a member of the CorDx Union, a biotechnology organization that delivers medical device solutions to healthcare industries and over a billion users in more than 170 countries.