Heavyweight | Jiu'an US subsidiary New Crown Antigen Home Self-Assessment OTC Kit Obtained US FDA Authorization
In the early morning of November 6th, the new coronavirus (SARS-CoV-2) antigen home self-test OTC kit (colloidal gold immunochromatography) of iHealth Labs Inc., a US subsidiary of Jiu'an Medical, was approved by the US Food and Drug Administration. (FDA) Emergency Use Authorization (EUA). Details of the authorization were also published on the FDA's official website on the same day.
During the U.S. public health emergency, iHealth COVID-19 Antigen Rapid Test EUA210470 can be sold in the U.S. and EUA-recognized countries/regions, and consumers can purchase it in e-commerce, pharmacies, supermarkets and other channels without a prescription. This product is mainly used for rapid and qualitative detection of the novel coronavirus (SARS-COV-2) in human anterior nasal swab samples in vitro. Individuals can collect anterior nasal swab samples for operation, and the results can be obtained in 15 minutes, making the detection process easier. It is more convenient, fast and low-cost, and it is convenient for individuals and families to conduct rapid and timely screening of new coronary pneumonia, and help local epidemic prevention and control.
In the context of the current overseas epidemic, quick and convenient self-test is one of the important means to block the spread of the epidemic. As the 9th approved company in the world with similar products, this EUA not only provides professional and reliable new coronavirus detection solutions for more regions and countries around the world, but also enriches the company's product line and improves the company's The core competitiveness and market expansion capabilities are an important breakthrough in the field of IVD, and it also marks that the overall product quality of Jiu'an Medical, which has been trusted by Chinese people for 26 years, has reached the international advanced level and entered the global high-end ranks.
In order to promote the internationalization strategy, Jiu'an Medical has vigorously developed overseas markets since 2002, actively participated in various international exhibitions, and frequently won a number of international awards for technology and design. It has gradually become a mainstream from an international market.
After stepping on the bigger stage, from 2011 to 2016, Jiu'an completed the layout of its mobile medical brand iHealth in three continents of Europe, America and Asia in 6 years. The success of this application also takes advantage of Jiu'an's years of experience in IVD and FDA applications.
Since the beginning of 2020, since the outbreak of the new crown epidemic, Jiu'an has actively fulfilled its social responsibility as a medical enterprise, and produced a variety of professional medical products represented by iHealth forehead thermometers, which have played an important role in epidemic prevention and control at home and abroad.
On the night of New Year's Eve on January 24, 2020, Jiu'an responded to Wuhan's anti-epidemic needs as soon as possible, and donated 1,000 iHealth forehead thermometers in stock to the epidemic area in Wuhan for free. On the fourth day of the Lunar New Year, the nine safety planes resumed work and raced against the epidemic, and urgently launched the recall of overseas reserves, expedited air transport to China regardless of cost, and delivered the iHealth forehead thermometer to meet the needs of domestic public health and epidemic prevention.
At the same time, in response to the needs of epidemic prevention, Jiu'an has coordinated optimization from technical solutions to production capacity, and production capacity has increased rapidly. As of April of that year, the single product output of iHealth forehead thermometers exceeded 1 million units, laying a solid material foundation for assisting the global fight against the epidemic.
With the outbreak of overseas epidemics, Jiu'an moved from the first half of domestic anti-epidemic to the second half of overseas anti-epidemic, and made every effort to raise various anti-epidemic materials including iHealth forehead thermometers, masks, etc., through Jiu'an subsidiaries in the United States, France and Singapore. As well as more than 100 business partners of Nine Safety Global, we deliver anti-epidemic materials to everyone who needs them, and play a role in temperature screening in major cooperative hospitals, family doctor clinics, government agencies, and service organizations to help prevent global epidemics. control.
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With the development and launch of more new products in the future, Jiu'an Medical, which insists on both quality and innovation, will continue to adhere to the spirit of excellence and pursuit of excellence, accelerate the pace of entering the global market, and contribute to enhancing the image and popularity of Chinese brands overseas. , to provide professional services of the highest quality standards for global partners and human life and health.
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