Osang Healthcare Received Emergency Use Authorization (EUA) by USFDA For COVID-19 Test Kit

Published : Monday, April 20, 2020, 1:32 pm
ACROFAN=Seunghee Shin | | SNS

Osang Healthcare, a subsidiary of OsangJaiel, announced that it obtained emergency use authorization (EUA) by the US Food and Drug Administration (FDA) on its COVID-19 test kit, GeneFinder™ COVID-19 Plus RealAMPKit. Osang Healthcare is a South Korean manufacturer and distributor of medical devices.

As the excellence of Korean test kits became known, competition around the world is fierce to secure Korean test kits. Currently, more than 100 countries have imported Korean COVID-19 test kits. With this FDA's EUA approval of Osang Healthcare, it is expected that the proportion of test kits in exports will increase significantly.

Osang Healthcare has begun negotiations to export to the US market in earnest through this EUA approval. Currently, specific discussions are underway for large-scale export contracts related to the supply of COVID-19 test kits to various channels in the United States.

Recently, the company has signed large-scale export contracts with Brazil, Russia, Italy, Romania, Morocco, Argentina, and the Federal Emergency Management Agency (FEMA). Besides, it is currently responding to export inquiries from over 70 countries around the world, and the produced quantity is shipped every week.

The company stated, "We already have expanded the production capacity so that there is no problem in supplying test kits in preparation for additional large-scale orders from the United States, South America, Europe, and the Middle East."

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