BioMérieux Gains IVDR Class D CE Marking for Syndromic Respiratory Panels

bioMérieux has announced that its BIOFIRE® Respiratory 2.1 plus Panel and BIOFIRE® FILMARRAY® Pneumonia plus Panel have obtained IVDR Class D CE Marking. This is the highest risk classification under the European Union's In Vitro Diagnostic Regulation. These panels are the first to include MERS-CoV, indicating a significant regulatory milestone for bioMérieux.

The panels offer multiplex testing, detecting multiple pathogens from a single sample in under an hour. Including MERS-CoV in these tests aids in rapid identification or exclusion of this pathogen alongside other respiratory agents, assisting clinicians in making timely treatment decisions.

This certification emphasizes bioMérieux’s dedication to providing innovative diagnostic solutions. The certified panels will be available on the European market early next year.