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FDA issues an EUA for STANDARD M nCoV Real-Time Detection Kit.

sdbiosensor 2020.04.24
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fda eua letter.jpg

 

US FDA gives EUA (Emergency Use Authorization) to STANDARD M nCoV Real-Time Detection Kit made by SD BIOSENSOR in 23 April, 2020.

 

STANDARD M nCoV Real-Time Detection Kit, which is approved by US FDA EUA, is used for rapid identification and detection of novel coronavirus (2019-nCoV) nucleic acids in human nasopharyngeal swabs and throat swab samples. This is RT-PCR test that amplifies and diagnoses a specific gene sequence of COVID-19.

 

With this approval, SD BIOSENSOR has the authority to supply STANDARD M nCoV Real-Time Detection Kit across the United States.