Bio-Rad has launched the CFX Opus deepwell Dx real-time PCR system, a real-time PCR system listed with the U.S. Food and Drug Administration (FDA) for in vitro diagnostic (IVD) testing, and developed in accordance with the European Union’s regulations for in vitro diagnostic medical devices (EU 2017/746). Bio-Rad will continue to seek regulatory approvals for additional global markets in the coming months.
The new system offers accurate and precise quantification with flexibility for reactions up to 125 µl in a 96-well format for quantitative PCR (qPCR) diagnostic assays. It is also available in a 96- and 384-well reaction block format. All systems in the Cproduct family are open platforms that can multiplex up to five targets to enable efficient IVD assay development and diagnostic testing. CFX Opus Dx real-time PCR systems offer easy-to-use desktop management and analysis software with integrated security features for electronic signature, audit, and user control.
"With the ongoing increase in demand for efficient and flexible IVD real-time PCR systems, we are pleased to announce the addition of the CFX Opus deepwell Dx real-time PCR system to the CFX Opus family,” said Steven Blakely, Senior Director for the Gene Expression Business, Bio-Rad. “The system continues in the tradition of robust and secure platforms that leverage our long-standing expertise in genomic tools to serve both research and clinical diagnostic markets,” he added.
