FDA Lists Bio-Rad’s CFX96 Dx Real-Time PCR System for IVD Testing
HERCULES, Calif., 05/18/2020 – Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that its CFX96 Dx Real-Time PCR System has been listed with the U.S. Food and Drug Administration (FDA) for IVD testing and may be used to help in the diagnosis of COVID-19. The FDA listing extends access to the instrument to assay developers and testing laboratories in the U.S.
Throughout the COVID-19 pandemic, the CFX96 Dx Real-Time PCR System has been used by laboratories outside the U.S. 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.
“We are pleased our CFX96 Dx Real-Time PCR System is now available for COVID-19 testing in U.S. 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.”
The CFX96 Dx Real-Time System joins other Bio-Rad products that are being used for the detection of COVID-19, including Bio-Rad’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.
