NanoEntek Obtains Export Approval for COVID-19 Antigen Diagnostic Kit
[Asia Economy Reporter Jang Hyowon] NanoEntek (CEO Jeong Chan-il) announced on the 6th that it has obtained export approval from the Korean Ministry of Food and Drug Safety for its COVID-19 antigen diagnostic kit (FREND COVID19 AG), which detects antigens of the novel coronavirus infection (COVID-19).
The COVID-19 antigen diagnostic kit directly tests for antigens entering the infected person's body through droplets, etc., so unlike antibody diagnostic kits, it can diagnose patients in the early stages of infection. It does not require expensive equipment like molecular diagnostics, making it affordable and easy to use, leading to rapidly increasing demand in developing countries with insufficient infrastructure.
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A NanoEntek representative stated, "Last week, we received emergency use authorization from the US FDA for the COVID-19 antibody diagnostic kit (FREND COVID-19 total Ab), strengthening our lineup of COVID-19 related products," and added, "Since the US is the largest market, we plan to obtain US FDA approval for all COVID-19 diagnostic products and enter the US market."
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