Eurobio Scientific is pleased to announce that our flagship product, EBX 071, has successfully obtained CE-IVDR certification, marking a significant milestone in regulatory compliance and product excellence.

Did you know that the WHO estimates around 400 million people worldwide are chronically infected with Hepatitis B virus, with 20 million also co-infected with Hepatitis delta virus? In many parts of the world, HDV prevalence remains unknown due to the lack of screening.

Since RNA detection is key to measuring viral replication and monitoring treatment response, Eurobio Scientific is proud to announce that we have received our first CE-IVDR certification for a class D product.

The CE-IVDR (In Vitro Diagnostic Regulation) certification ensures that EBX 071 meets the highest European standards for safety, performance, and reliability in the in vitro diagnostics industry. This achievement reinforces our commitment to delivering high-quality diagnostic solutions that healthcare professionals can trust.

EBX 071 has been developed with cutting-edge technology to provide accurate and efficient diagnostic results. Our test is based on quantitative real-time PCR to detect and quantify HDV RNA in the blood of infected patients. The CE-IVDR certification allows us to expand our market reach across Europe and enhance our ability to support medical professionals with advanced diagnostic tools.

“We are proud to receive CE-IVDR certification for EBX 071. This milestone reflects our dedication to quality and innovation in the diagnostic field,” said by our R & D team.

For more information about EBX 071 and its benefits, please contact us.