CE mark

Bio-Rad Laboratories Earns CE Mark for RT-PCR COVID-19 Test Kit

May 6, 2021

Bio-Rad Laboratories has received CE mark certification for its Reliance SARS-CoV-2 real-time reverse transcription polymerase chain-reaction (RT-PCR) test kit.

The test, which identifies the presence of SARS-CoV-2 by detecting nucleic acid in the virus, is designed for use in clinical laboratories. It uses nasopharyngeal swabs from patients suspected of infection and runs on the company’s CFX96 Dx RT-PCR system as well as other RT-PCR systems.

The company said the test’s performance is unlikely to be adversely impacted by known COVID-19 viral variants. A version of the test kit previously received the FDA’s Emergency Use Authorization.

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