Jiu’an Medical: Subsidiary’s New Crown Antigen Rapid Detection POC Professional Edition Kit has been authorized by the US FDA for emergency use jqknews

On the evening of January 16th,Jiu’an MedicalannouncementAccording to the company, in the early morning of January 15, 2022, Beijing time, the company was authorized by the U.S. Food and Drug Administration (FDA). Colloidal Gold Immunochromatography) received Emergency Use Authorization (EUA) and received authorization letter from FDA to U.S. subsidiary. Thereafter, the product is available for use in the United States and in countries that recognize the U.S. FDA EUA during the U.S. public health emergency.

According to the announcement, the product is mainly used for the rapid and qualitative detection of the novel coronavirus (SARS-CoV-2) in human anterior nasal swab samples in vitro. The product must be tested by professional medical staff or personnel who are skilled in using the kit product in accordance with the product instructions for use. The results can be obtained within 15 minutes, which can be used by professional medical staff. And the personnel who can skillfully use the kit product in the scene of on-site nursing can use it in the screening of new coronary pneumonia to help prevent and control the epidemic.

　　Jiu’an MedicalSaid that the product has enriched the company’s new crown antigen detection product line through emergency use authorization, can help public health and epidemic prevention work to a greater extent, and provide professional new crown virus detection solutions for public health and epidemic prevention work. sales revenue andperformance。

However, the company also reminded that the overseas sales of the iHealth New Crown Antigen Rapid Detection POC Professional Edition Kit of the US subsidiary is closely related to the development of the epidemic. Due to the influence of various factors such as the research and development situation, the validity period of the product emergency use authorization, and the development and changes of the market, after the product has obtained the emergency use authorization of the United States, the company is still unable to predict that the product will be given to the company in the future.Operating incomeand performance impact.

(Article source: Chinasecuritiesnewspaper)

Article source: China Securities Journal

Responsible editor: 83

Original title: Jiu’an Medical: Subsidiary’s New Crown Antigen Rapid Detection POC Professional Edition Kit has been authorized by the US FDA for emergency use