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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » BGI Coronavirus Molecular Diagnostic Test Garners CE Mark

BGI Coronavirus Molecular Diagnostic Test Garners CE Mark

Mar 02, 2020
|
staff reporter

NEW YORK – BGI said late on Friday that its Real-Time Fluorescent RT-PCR kit for detecting SARS-CoV-2 (also known as 2019-nCoV) has received CE-IVD marking and is now commercially available in markets recognizing the designation.

BGI's kit is a qualitative in vitro nucleic acid amplification assay that detects 2019-mCoV, the cause of COVID-19, using reverse transcriptase PCR from throat swab and bronchoalveolar lavage fluid samples.

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