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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.

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