UPDATE : Friday, July 10, 2020
Wells Bio’s Covid-19 diagnostic kit wins urgent use permit
  • By Lee Han-soo
  • Published 2020.06.01 11:24
  • Updated 2020.06.01 16:14
  • comments 0

Wells Bio said that it has obtained emergency use approval for careGENE™ N-CoV RT-PCR Kit, a Covid-19 test kit, from the Ministry of Food and Drug Safety.

Wells Bio will speed up local and overseas sales of the product through collaboration with its marketing partner, Wooridul Pharmaceuticals. The company’s diagnostic kit, which uses real-time gene amplification method, obtained Conformite Europeenne (CE) certification in EU and an export approval from the ministry in May.

“With the approval of the emergency use from the Ministry of Food and Drug Safety, the company will now be able to supply the diagnostic kit in Korea as well as overseas, in collaboration with Wooridul Pharmaceuticals,” a company official said. “We expect the approval will accelerate the global market entry and sales of the product.”


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