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Bio-Rad’s CFX96 Dx Real-Time PCR System Listed with FDA for IVD Testing

By LabMedica International staff writers
Posted on 19 May 2020

Image: Bio-Rad’s CFX96 Dx Real-Time PCR System (Photo courtesy of Bio-Rad Laboratories, Inc.)

Bio-Rad Laboratories, Inc.’s (Hercules, CA, USA) CFX96 Dx Real-Time PCR System has been listed with the US Food and Drug Administration (FDA) for IVD testing and may be used to help in the diagnosis of COVID-19.

Throughout the COVID-19 pandemic, the CFX96 Dx Real-Time PCR System has been used by laboratories outside the US that require an IVD platform to detect SARS-CoV-2. The system has also met the CE mark requirements for IVD use in Europe and is registered with regulatory bodies for IVD use in many other countries. The FDA listing now extends access to the instrument to assay developers and testing laboratories in the US.

The CFX96 Dx Real-Time System joins other Bio-Rad products that are being used for the detection of COVID-19, including the company’s SARS-CoV-2 Droplet Digital PCR (ddPCR) Kit; Platelia SARS-CoV-2 Total Ab assay; and the SARS-CoV-2 Standard, which is used to support laboratory assay validation of COVID-19 testing.

"We are pleased our CFX96 Dx Real-Time PCR System is now available for COVID-19 testing in US markets," said Annette Tumolo, Bio-Rad Executive Vice President, President, Life Science Group. "By identifying those who test positive for the virus, individuals can be quarantined and receive treatment more quickly, helping to contain the spread of this disease."

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