Humasis Receives MFDS Manufacturing Approval for COVID-19 and Flu Simultaneous Diagnostic Kit

Professional Products
Plan to Proceed with US FDA Approval

Humasis Central Research Institute announced on the 20th that it has obtained domestic manufacturing approval from the Ministry of Food and Drug Safety for a product that can simultaneously detect COVID-19 and influenza infections.

Humasis CI. [Image provided by Humasis]

The newly approved 'Humasis COVID-19/Influenza Antigen Combo Test' is a professional-use product that can confirm results within 15 minutes from a single nasopharyngeal swab specimen collected from a person suspected of infection. This product allows simultaneous interpretation of COVID-19 infection status in the left result window and influenza infection status in the right result window using a single device.

A Humasis official stated, "Since infection status can be confirmed with just one specimen collection when both influenza and COVID-19 diagnosis are needed, demand is expected to increase during the twin-demic period when both diseases are prevalent." They added, "In the future, this diagnostic reagent will further demonstrate its efficacy through clinical trials in the United States and Europe and plans to obtain additional certifications from various countries overseas."

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