Weiyun obtains CE Certification of EU Market Access for IgM/IgG Antibody Fast Detection Kit

03:20 PM| Friday,March 20, 2020

NANJING, March 20, 2020 -- Jiangsu Weiyun Biomedical (Nanjing) Co., Ltd. (hereinafter referred to as Weiyun), the leader in serving genetic products and services in China, announced today that Weiyun has completed the European In Vitro Diagnostic Medical Devices Directive (IVDD) compliance statement and registration in the European Union for its diagnostic product, SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold), that can be used for fast large-scale screening of SARS-CoV-2, the virus that causes COVID-19, and has been qualified for EU market access.


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The SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) developed by Jiangsu Weiyun Biomedical (Nanjing) Co., Ltd. can be used to provide quick and convenient field tests for suspected patients, asymptomatic patients, close contacts, and nucleic acid negative suspects. This product successfully integrates the S protein and the N protein of SARS-CoV-2 into one test card, which simultaneously detects two types of specific antibodies IgM and IgG released by the subjects. The operation is fast and simple, the results can be read in 3 minutes without instrument, and the whole process including blood-taking takes only 8 minutes.

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"Our diagnostic kit for COVID-19 will help medical institutions for disease control and prevention, and with this CE certification, we can better serve the clients in overseas countries," said Huang Pian, chief executive officer of Weiyun International Business Department. "At Weiyun, we take "Science and Technology Serves Public Security" as our mission and are committed to becoming a comprehensive provider of products, services, solutions and training in gene industry. As the saying goes, "Science has no borders", in the face of the raging COVID-19, our company will make every effort to help clients overcome the epidemic."


At present, the global COVID-19 epidemic situation is severe. South Korea, Italy, Iran, Japan and other countries in the world have been showing an outbreak trend. This CE certified SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) of Weiyun will definitely contribute to the prevention and control of COVID-19 worldwide.



About Jiangsu Weiyun Biomedical (Nanjing) Co., Ltd.

Jiangsu Weiyun Biomedical (Nanjing) Co., Ltd., founded in August 2011, is a national high-tech enterprise integrating R&D and production. After years of development, Weiyun has established a series of DNA database service centers, food/medicine/environment safety testing laboratories, forensic science and medical test kit R&D centers, medical testing laboratories, biological information centers and other platforms. Weiyun has cooperated with over 20 judicial identification centers to provide judicial identification, public security technical equipment and services to more than 200 cities and 1,200 public security bureaus. The company has also established long-term cooperative scientific research relationships with well-known universities such as the People's Public Security University of China, Southwest University of Political Science & Law, and Criminal Investigation Police University of China.

Being a comprehensive provider of products, services and solutions in gene industry, Weiyun takes “Science and Technology Serves Public Security" as its mission, and adheres to the customer-oriented business concept, striving for creating a healthier and safer living environment for people.


SOURCE Jiangsu Weiyun Biomedical (Nanjing) Co., Ltd.






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