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Received a ‘Commendation from the Minister of Food and Drug Safety’ at the event on Medical Device Day

  • 운영자
  • Date 2021.01.26
  • Hit 38
Seasun Biomaterials received a commendation from the Ministry of Food and Drug Safety in recognition of its contribution to the molecular diagnosis field.

At the '13th Medical Device Day' commemorative event held at the Imperial Palace Hotel in Seoul on the 20th, Sisun Bio received a commendation from the Minister of Food and Drug Safety in recognition of its contribution to the spread and quarantine of a novel coronavirus infection (COVID 19).23 Sun said.

The medical device day commemorative event commemorates the day of the enactment and promulgation of the Medical Device Act, and is a place to commemorate the achievements of those who have contributed to the development of domestic medical technology and public health. On this day, in order to keep the distance from COVID 19, only some of the winners attended, and a YouTube broadcast was held at the same time for those who could not come.

SeasunBio is a molecular diagnosis company that has various disease diagnosis technologies such as cancer and other brain diseases, fetal genetic problems, and infant/child hearing loss based on human genetic information.

SeasunBio's COVID-19 related diagnostic products are'Utopcovid 19 Detection Kit (Utop)','Utopcovid 19 Detection Kit Plus (Utopplus)','Actopcovid 19 Rapid Detection' based on real-time PCR molecular diagnosis. There are'Kit (AQ Top)' and'AQ Top Covid 19 Rapid Detection Kit Plus (AQ Top Plus). Among them, UTOP, AQTOP, and AQTOP PLUS are products that have received emergency approval from the US Food and Drug Administration (FDA), and UTOP PLUS is a product that has obtained official approval from the Ministry of Food and Drug Safety.

In addition, on the 4th, “Utopsascove-2 & Fluavi (Utopsasflu)”, which can diagnose Corona 19 and flu virus at the same time, received an export license from the Ministry of Food and Drug Safety. Utopsasplu has completed European CE-IVD certification and is undergoing document review for emergency use approval by the US FDA.

In addition, SeasunBio's COVID 19 diagnostic product was recognized as a world-class molecular diagnosis technology by receiving a top ranking in the sensitivity evaluation of the product approved for emergency use of COVID 19 by the US FDA in September.

Park Hee-kyung, CEO of Seasun Bio, said, "We will try to popularize and distribute medical devices that can be customized and precise diagnosis based on genetic information." By doing so, I will contribute to opening a healthy age of 100 years.”

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관련전문:
https://www.ekn.kr/web/view.php?key=20201123010005431
http://www.healthinnews.co.kr/news/articleView.html?idxno=20248
http://www.economytalk.kr/news/articleView.html?idxno=209499
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