Skip to main content
Premium Trial:

Request an Annual Quote

Bio-Rad Real-Time PCR Platform Listed by FDA for IVD Testing

NEW YORK – Bio-Rad said on Monday that its CFX96 Dx real-time PCR instrument has been listed with the US Food and Drug Administration for in vitro diagnostic testing. 

The listing enables assay developers and testing labs in the US to access the instrument for COVID-19 testing, the firm said.

In a statement, Bio-Rad noted that the CFX96 Dx Real-Time PCR System has been used outside the US by laboratories requiring 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 in other countries as well.

"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 and president of the firm's 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," Tumolo said. 

Bio-Rad's other products being used for the detection of COVID-19 include the SARS-CoV-2 Droplet Digital PCR Kit, the Platelia SARS-CoV-2 Total Ab assay, and the SARS-CoV-2 Standard which is used to support laboratory assay validation.