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CE mark

Bio-Rad Laboratories Gains CE Mark for COVID-19 Plus Flu Test

July 19, 2021

Bio-Rad Laboratories has received CE mark certification for its Reliance SARS-CoV-2/FluA/FluB RT-PCR Kit, a combined COVID-19 and influenza assay.

The assay, which is for use in clinical laboratories, can detect the N gene of the SARS-CoV-2 virus that causes COVID-19, as well as the M1 gene of the influenza A virus and the NS2 gene of the influenza B virus, all from a nasal swab.

The assay is validated for use with Bio-Rad's CFX96 DX polymerase chain reaction (PCR) instruments, but it can also run on PCR systems made by other companies, Bio-Rad said.

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