Osang Healthcare Surpasses 10 Million Cumulative Orders for COVID-19 Diagnostic Kits

[Asia Economy Reporter Oh Ju-yeon] Osang Healthcare, a subsidiary of Osang Jaiel specializing in medical diagnostic devices, announced on the 24th that since receiving export approval from the Ministry of Food and Drug Safety on the 18th of last month, the cumulative order volume of its COVID-19 diagnostic kits from over 30 countries worldwide has exceeded 10 million units. All ordered quantities are expected to be shipped by the end of this month.

A company official stated, "So far, we have supplied COVID-19 diagnostic kits to more than 30 countries including the United States, Brazil, Russia, Italy, Romania, Morocco, Kuwait, and Argentina. To export COVID-19 diagnostic kits, it is necessary to pass the stringent technical requirements demanded by each country's regulatory bodies, among which the U.S. Food and Drug Administration (FDA) is known as the most formidable barrier." Osang Healthcare was the first in Korea to obtain FDA Emergency Use Authorization (EUA) on the 18th, and unlike other products with EUA, it received approval as a universal kit compatible with almost all equipment, enabling supply of diagnostic kits throughout the United States.

Lee Dong-hyun, CEO of Osang Healthcare, said, "The process of obtaining the FDA Emergency Use Authorization, which requires rigorous technical standards, was by no means easy. This achievement was possible thanks to the united efforts of all employees, including the U.S.-dedicated research team and quality team, based on 20 years of accumulated technology in the diagnostic device field."

The company added, "In preparation for a sharp increase in export volumes to the U.S. and other countries due to the FDA Emergency Use Authorization, we have expanded production capacity to ensure there are no supply issues." They also noted, "Exports are expected to increase significantly not only to the U.S. but also to countries such as Italy, France, Russia, Canada, Argentina, India, and Qatar, where individual FDA Emergency Use Authorizations have been obtained."

This content was produced with the assistance of AI translation services.