May 26, 2020—Bio-Rad Laboratories announced that its CFX96 Dx Real-Time PCR System has been listed with the 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 United States
“We are pleased our CFX96 Dx Real-Time PCR System is now available for COVID-19 testing in U.S. markets,” 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 system has also met CE mark requirements for IVD use in Europe and is registered with regulatory bodies for IVD use in many other countries, the company says.