Thermo Fisher Scientific announced on Monday that its Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR (RT-PCR) system meets In Vitro Medical Devices Regulation (IVDR) requirements.
The updated system now includes the firm's Applied Biosystems Diomni Software ecosystem to enable clinical labs and test developers to leverage flexible PCR testing onsite, Thermo Fisher said.
Whether performing a routine test or developing a new assay, the integrated, IVDR-compliant Applied Biosystems Diomni Software ecosystem is designed to streamline the entire workflow with a plug-and-play design and simplified setup to enhance efficiency and minimize user error, Thermo Fisher said.
The centralized setup allows connection to multiple RT-PCR instruments and secure data-sharing across a user network, the firm added.
"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," Fernando Beils, vice president and general manager of qPCR instruments at Thermo Fisher Scientific, said in a statement.
The QuantStudio 7 Pro Dx Real-Time PCR System is listed as a class II medical device with the U.S. Food and Drug Administration (FDA), Thermo Fisher said. It is also available in all regions recognizing CE-IVD certification.