QIAGEN announced on September 10, 2025, that it has achieved CE-IVDR certification for its full portfolio of QIAstat-Dx syndromic testing systems and panels. This certification ensures compliance with the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR), which harmonizes requirements for IVD devices to improve patient safety and transparency.
The certification includes an expanded Meningitis/Encephalitis (ME) Panel, which now offers the broadest coverage available for central nervous system (CNS) infections with 16 clinically relevant targets, including cytomegalovirus (CMV) and Streptococcus pyogenes. The launch of this enhanced panel is expected in September 2025.
QIAstat-Dx systems, including both the Analyzer and the higher-capacity Rise versions, received CE-marking under the IVDR framework late last year. With over 4,600 QIAstat-Dx systems installed globally by the end of 2024, this certification reinforces QIAGEN's commitment to providing reliable diagnostics that meet the highest quality standards for clinicians and laboratories across Europe.
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