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Bio-Rad Laboratories Gets CE Mark for SARS-CoV-2 Kit

NEW YORK – Bio-Rad Laboratories announced on Tuesday that it has received CE-IVD mark for a kit to detect SARS-CoV-2. The test kit is now launched in European markets.

The Reliance SARS-CoV-2 RT-PCR Kit is a real-time reverse-transcriptase PCR test that detects the N1 and N2 regions of the nucleocapsid gene from nasopharyngeal swab samples. The kit contains the firm's controls as well as assay reagents and is validated on Bio-Rad's CFX96 Dx RT-PCR system as well as other RT-PCR systems.

"The assay kit is the latest addition to our COVID-19 offering of research and testing products, reflecting our ongoing commitment to helping in the fight against COVID-19," said Steven Blakely, Bio-Rad's global director of marketing for the gene expression division of the life science group.

The Reliance SARS-CoV-2 RT-PCR Kit was previously granted Emergency Use Authorization by the US Food and Drug Administration in January.