SD Biosensor Coronavirus PCR Test Receives FDA Emergency Use Authorization

SD Biosensor, INC. (Suwon, Gyungido, Korea) has secured EUA (Emergency Use Authorization) from the US FDA for its STANDARD M nCoV Real-Time Detection Kit. The kit is used for rapid identification and detection of novel coronavirus (2019-nCoV) nucleic acids in human nasopharyngeal swabs and throat swab samples. With the approval, SD BIOSENSOR has the authority to supply STANDARD M nCoV Real-Time Detection Kit across the US.

The STANDARD M nCoV Real-Time Detection kit is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider. It has been designed according to “WHO interim guidance for laboratory testing for 2019 novel coronavirus (2019-nCoV) in humans." The STANDARD M nCoV Real-Time Detection kit can be used to test in nasopharyngeal, oropharyngeal, nasal, and mid-turbinate nasal swab specimens, and sputum. The RT-PCR test amplifies and diagnoses a specific gene sequence of COVID-19. It offers a one tube reaction for identification and detection of 2019-nCoV and includes all the reagents required for PCR. The test also includes nCoV primers/probes ORF1ab (RdRp) gene, E gene, as well as internal controls.


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