Devices are now classified by risk level, from A (lowest risk) to D (highest risk). The QIAstat-Dx instruments, QIAstat-Dx Analyzer 2.0 and QIAstat-Dx Rise, are classified as Class A devices, while the QIAstat-Dx Gastrointestinal Panel 2 is classified as a Class C device. The QIAstat-Dx Respiratory Panel Plus is classified as a Class D device – the highest risk category – highlighting QIAGEN's capabilities to meet highest regulatory thresholds in Europe. The submission for IVDR certification of the QIAstat‑Dx Meningitis/Encephalitis Panel is expected in the coming months. "Achieving IVDR certification for our QIAstat-Dx systems and panels is a significant milestone for QIAGEN," said Fernando Beils, Senior Vice President and Head of QIAGEN's Molecular Diagnostics Business Area.