Thermo Fisher Scientific Certifies Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System to Meet IVDR Requirements


The Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System has received certification from Thermo Fisher Scientific to confirm that it complies with the new In Vitro Medical Devices Regulation (IVDR) standards. A new, complementary Applied Biosystems Diomni Software environment has been added to the revised system to enable clinical labs and test developers to take advantage of flexible PCR testing on-site.

The QuantStudio 7 Pro Dx Real-Time PCR System is built for optimal productivity and quick ramp-up, and it enables customers to move from development to validation on a single system. The 96-well and 384-well blocks on the expandable, automated platform can be swapped out, and it also has touchscreen, remote desktop, facial recognition, voice command, and smart tech support to boost user productivity.

“We have continued to support our customers throughout the transition to IVDR, first by introducing the updated Applied Biosystems QuantStudio 5 Dx Real-Time PCR System earlier this year and now with the launch of the IVDR-compliant QuantStudio 7 Pro Dx Real-Time PCR System and new complementary Diomni Software ecosystem”, “As test developers and laboratories expand their assay menus and IVD testing capabilities, we are committed to continue providing innovative solutions to meet their evolving needs.”

Fernando Beils, vice president and general manager of qPCR instruments at Thermo Fisher Scientific

The integrated, IVDR-compliant Applied Biosystems Diomni Software ecosystem is built to streamline the whole process, whether conducting a standard test or creating a new assay. It features a plug-and-play design and a streamlined setup to increase efficiency and reduce user error. The centralised setup enables secure data sharing between users on a network and connecting to numerous real-time PCR devices.

“The ability to import plate set-up files from external software and export result sets in a customizable structure made it easy to integrate the QuantStudio 7 Pro Dx Real-Time PCR System with our laboratory information management software”, “The new Diomni Software makes it easy to work collaboratively and we can set up runs, manage past runs and documentation, and interpret fluorescent curves remotely and efficiently without the need to install special software.”

Dr. Gustav Quade, laboratory medicine and technical development specialist at the Quade Laboratory in Germany

All nations that accept the CE-IVD certification can purchase the QuantStudio 7 Pro Dx Real-Time PCR System, which is also registered with the US. FDA classifies the item as a class II medical device.

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