QIAGEN gains 510(k) clearance by FDA for QIAstat-Dx in the U.S. and launches system as next generation platform for syndromic insights
(WorldNews Health)

Germantown, Maryland, and Hilden, Germany, May 20, 2019 -QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. launch of its QIAstat-Dx syndromic testing system after receiving 510(k) clearance by the U.S. Food and Drug Administration, along with the multiplex QIAstat-Dx® Respiratory Panel for simultaneous qualitative detection and identification of multiple respiratory viral and bacterial pathogens. QIAstat-Dx (formerly Stat-Dx DiagCORE®) represents the next-generation in multiplex molecular diagnostic systems that enables fast, cost-effective and flexible syndromic testing with novel Sample to Insight solutions powered by QIAGEN chemistries. The system, based on...