SML Genetree, Covid19 Diagnostic Kit Acquires Emergency Use Authorization from MFDS.
SEOUL, Korea, June 24, 2020 - SML Genetree’s rapid Covid19 diagnostic kit, Ezplex SARS-CoV-2 FAST Kit has obtained emergency use authorization from Korea Ministry of Food and Drug Safety (MFDS; Director: Eui-Kyung Lee).
The emergency use authorization of the Covid19 emergency diagnostic reagent is limited to products that are able to derive results within an hour from specimen preparation, which will allow rapid Covid19 infection testing for patients in emergency situations.
SML Genetree has received export approval for the Ezflex® 2019-nCoV Real-time PCR Kit from the Ministry of Food and Drug Safety and has obtained the European Commission CE-IVD (In Vitro Diagnostics) Certification.
Original Article: (Dong-A Ilbo) https://n.news.naver.com/article/020/0003293929?lfrom=kakao 2