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

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  • Date 2021.01.26
  • Hit 7,935
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, SeaSun Biomaterials 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.

SeaSun Biomaterials 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.

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

In addition, on the 4th, “U-TOP SARS-CoV-2 & Flu A/B”, which can diagnose COVID-19 and flu virus at the same time, received an export license from the Ministry of Food and Drug Safety. U-TOP SARS-CoV-2 & Flu A/B has completed European CE-IVD certification and is undergoing document review for emergency use approval by the US FDA.

In addition, SeaSunBiomaterials'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 Biomaterials, 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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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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