The Ministry of Food and Drug Safety announced that it has granted conditional approval today (23rd) for two antigen-type diagnostic kits that can self-test for Corona 19.
The two diagnostic kits, respectively, are SD Biosensor and Humasys products, which were previously licensed for professional use in Korea, and emergency use approval for self-testing abroad.
Conditional authorization is a system that allows temporary use of additional clinical performance test data, etc., within 3 months before the officially licensed product is released.
The Ministry of Food and Drug Safety emphasized that the two products should be used only as an auxiliary means, not for confirming Corona 19.
The final decision should be made by a doctor, taking into account the results of genetic testing (PCR) and clinical symptoms.
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