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U.S. FDA urgent use approval for COVID 19 specimen collection kit

  • 운영자
  • Date 2021.01.26
  • Hit 36
Seasun Biomaterials' TOP Virus Collection Kit, a product for collecting samples for corona 19 diagnosis, was officially approved by the Ministry of Food and Drug Safety in July, followed by the Food and Drug Administration (FDA) on the 10th (local Time) It announced on the 11th that it has received an emergency use approval (EUA).

This sample collection kit includes two types of nasopharyngeal swabs and oropharyngeal swabs, which are tools for collecting samples by scraping the walls of the nasal cavity and oral cavity, and a sample transport medium (It consists of a viral transport medium (VTM).

The sample transport medium contains a red indicator, so that external contamination can be determined visually. In addition, antibiotics to prevent bacteria and contaminants and a stabilizer to prevent the decomposition of viral nucleic acids, which are important for COVID 19 testing, are also included, making it possible to diagnose flawless and ultra-precise COVID 19.

Currently, there are a total of 18 items of sample transport media approved for emergency use by the US FDA for the diagnosis of COVID 19.

The company's COVID-19 diagnostic reagents'U-TOP COVID-19' and'AQ-TOP COVID-19 Rapid' were released in April and May, respectively. It has been approved for emergency use by the FDA for precise diagnosis and rapid diagnosis of COVID 19.

From last March, when COVID 19 began to spread, Seasun Bio has built a system and reached the completion stage of a one-stop diagnostic platform that continuously proceeds from sample collection to result analysis.

관련전문:
http://www.mdtoday.co.kr/mdtoday/index.html?no=398881
https://www.etnews.com/20200914000070
https://www.hankyung.com/it/article/202009110515i
http://www.wowtv.co.kr/NewsCenter/News/Read?articleId=A202009110349&t=NN
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