Celltrion said Sampinute delivers coronavirus test results within 10 minutes, with a sensitivity of around 94%.
The authorisation came three months after requesting approval in late July and the product has already been launched in the United States in August, according to the company statement.
“(The company) is planning to supply Sampinute across the United States through local wholesalers as it believes the demand for rapid diagnosis kits will be high, mainly among large businesses and government agencies that are about to return to work after telecommuting,” it said in a statement.
Shares of Celltrion Inc surged as much as 4.6%, while Celltrion Pharm and Celltrion Healthcare jumped 4.6% and 1.6%, respectively. Broader KOSPI, however, was trading down 0.1% as of 0208 GMT.