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https://www.fda.gov/media/136473/download

美國FDA當地時間3月26日緊急頒發給中國的華大基因（BGI Genomics Co.Ltd）緊急授權，
允許華大基因的新冠病毒RT-PCR檢測試劑盒（Real-Time Fluorescent RT-PCR Kit for
Detecting SARS-2019-nCoV）進入美國銷售。

1. The SARS-CoV-2 can cause a serious or life-threatening disease or conditi
on,including severe respiratory illness, to humans infected by this virus;
新冠病毒可導致嚴重或危及生命的疾病，或對受該病毒感染的人造成包括嚴重呼吸道疾
病在內的嚴重后果。

2. Based on the totality of scientific evidence available to FDA, it is reas
onable to believe that your product may be effective in diagnosing COVID-19, and that the know
n and potential benefits of your product when used for diagnosing COVID-19, outwei
gh the known and potential risks of your product; and
基于FDA可獲得的全部科學證據，有理由相信您的產品可能對診斷COVID-19有效，并且您的
產品在用于診斷COVID-19時的已知和潛在益處超過了您產品的已知和潛在風險。并且，

3. There is no adequate, approved, and available alternative to the emergenc
y use of your product.
沒有足夠的、經批準的、可用的替代品來緊急替代使用你的產品。

心得：
快去警告美國爸爸不要用中國的黑心病毒檢測盒！

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