QIAGEN (QGEN) has announced that its QIAstat-Dx syndromic testing systems, along with their associated assays, have gained CE-marking compliance under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR).
This certification encompasses the widely-utilized QIAstat-Dx Analyzer, the QIAstat-Dx Rise, and diagnostic panels designed for the detection of gastrointestinal and respiratory illnesses.
QIAGEN has indicated that it is on schedule to transition over 180 products to conform with the new IVDR regulatory standards.
The QIAstat-Dx system is available in two configurations: the standard QIAstat-Dx, which integrates up to four Analytical Modules into a single cohesive unit, and the QIAstat-Dx Rise, a higher-capacity version capable of conducting up to 160 tests per day utilizing eight Analytical Modules.
