Innovative qPCR System for In Vitro Diagnostic Use Launched

Thermo Fisher Scientific today announced the completion of the US Food and Drug Administration (FDA) listing for the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System. The innovative product enables clinical laboratories and assay developers to meet testing demands and enhance their molecular diagnostics workflows.  
 
Clinical diagnostic and hospital laboratories across the United States have ramped up PCR testing over the last year in response to the global COVID-19 pandemic. These laboratories are now seeking solutions to continue to screen for COVID-19 after emergency use authorisations (EUAs) for SARS-CoV-2 assays expire. 
  
The high-performing qPCR system’s simplified, efficient workflow minimises steps to deliver quality results in as little as 30 minutes. The system has high sensitivity and specificity and offers up to six channels for multiplexing. The cost-effective and complete solution, including simplified software, enhanced security and a simple-to-use interface, comes in a compact footprint that can fit in any lab. 

The QuantStudio 5 Dx Real-Time PCR System is listed with the FDA, includes the CE-IVD Mark under the self-certification process in the European Union, and has been certified and approved by the National Medical Products Administration (NMPA) in China. The system is currently registered in more than 50 countries. 
 
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