Approval of Clinical Trial Plan for COVID-19 and Influenza Simultaneous Diagnostic Kit
[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety announced on the 8th that it approved the clinical trial plan for one in vitro diagnostic reagent (diagnostic kit) that simultaneously diagnoses COVID-19 and influenza (flu) the day before.
So far, clinical performance test plans for three products from two manufacturers have been submitted. Among these, one case was approved this time.
The approved product collects specimens in the same way as the COVID-19 test and can simultaneously test for two types of viruses: the COVID-19 virus and the influenza virus.
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The Ministry of Food and Drug Safety plans to support the rapid approval of the in vitro diagnostic reagent through clinical trials.
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