Osang Healthcare Obtains US FDA Emergency Use Authorization for COVID-19 Diagnostic Kit

[Asia Economy Reporter Oh Ju-yeon] Osang Healthcare, a subsidiary of Osang Jaeil, announced on the 19th that it has obtained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 diagnostic kit.

As the excellence of Korean diagnostic kits has become well known, countries around the world are fiercely competing to secure Korean-made diagnostic kits. Currently, more than 100 countries import Korean COVID-19 diagnostic kits, and with Osang Healthcare's recent FDA approval, the share of COVID-19 diagnostic kits in total medical device exports is expected to increase significantly.

An Osang Healthcare official stated, "With this FDA Emergency Use Authorization, the company has begun additional negotiations for full-scale entry and sales in the U.S. market beyond the already contracted Federal Emergency Management Agency (FEMA). We are currently engaged in detailed discussions with multiple channels within the U.S. for large-scale export contracts related to the supply of COVID-19 diagnostic kits."

Recently, Osang Healthcare signed large-scale export contracts with Brazil, Russia, Italy, Romania, Morocco, Argentina, FEMA, and others. In addition, the company is responding to a flood of export inquiries from over 70 countries worldwide, and the produced quantities are being shipped weekly.

A company representative said, "With FDA approval, the company has expanded production capacity to ensure no issues in supplying diagnostic kits in preparation for large additional orders from the U.S., South America, Europe, and the Middle East. We expect continuous love calls for export contracts and business partnerships from major global bio investors."

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