Huada gene new coronavirus nucleic acid testing kit through Japan PMDA certification
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Last Update: 2020-05-30
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Source: Internet
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Author: User
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The product name is: New Coronary Virus 2019-nCoV Nucleic Acid Testing Kit (Fluorescent PCR Method)intended use: This kit is suitable for suspected patients with pneumonia with new coronavirus infection or other persons who need to diagnose or identify new coronavirus infection, by detecting nucleic acids taken from upper respiratory tract samples (pharynx swabs) or lower respiratory tract samples (alveoli irrigation) taken from the subject to determine whether the subject has a new coronavirus infectionthe product is certified for the product, which requires testing to assess clinical performance after production and sale, and stability testing under actual storage conditions, due to the very limited data at the time of approvalannouncement shows that the company has obtained the National Drug Administration of China issued a medical device registration certificate, completed the EU CE certification, and obtained the European Union free sales certificate, at the same time, the product has been issued by the U.SFood and Drug Administration ("FDA") issued emergency use authorization (EUA).
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