www.fdanews.com/articles/207962-qiagen-gets-ce-mark-for-higher-capacity-qiastat-dx-rise-and-enhanced-test-panels
Qiagen Gets CE Mark for Higher Capacity QIAstat-Dx Rise and Enhanced Test Panels
May 25, 2022
Qiagen has received a CE mark for its QIAstat-Dx Rise, a high-capacity version of its QIAstat-Dx automated syndromic system for diagnostics, along with enhancements to its menu of tests.
The new CE mark certification allows operators to run new respiratory and gastrointestinal panels.
The company’s QIAstat-Dx Respiratory SARS-CoV-2 panel, which also has a CE mark, has been expanded to detect 23 pathogens, including Chlamydophila pneumoniae bacteria that are a major cause of respiratory infections.
The system, which can process up to 56 tests in an eight-hour shift, provides results in about one hour.