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Established in 1997, located in Shanghai Hi-Tech Medical Device Park, China, the company is specialized in R&D, manufacturing, distribution and sales of IVD diagnostic devices and reagents. Its main products include the testing items of kidney diseases, cardiovascular diseases, inflammatory & infectious diseases and reproduction. It has certified to ISO9001 and TUV SUD ISO13485. Engaged in point of care area, the Chinese company has launched 7 instrument platforms and more than 30 kinds of reagents to the market, some of which are sold in Europe and Southeast Asia.
To further expand the international market, currently, the Chinese company is looking for European distributors for their 3 kinds of test kits and the matched instruments, namely COVID-19 related test kits, infectious factors test kits and cardiac markers test kits. They could also offer OEM(Original Equipment Manufacturer) services for overseas clients with in vitro diagnostic products distribution abilities.

Advantages & innovations

Regarding COVID-19 related test kits: The company’s COVID-19 related test kits include Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test, SARS-CoV-2 Real-time PCR (Real-time Polymerase Chain Reaction) Test Kit, Diagnostic Kit for CRP and SAA (C-reaction protein and Serum Amyloid A) Multiplex Test (Fluorescence Lateral Flow Immunoassay). As the outbreak of COVID-19, the company has developed the antibody test kits and RT-PCR test kits. Together with the infection indicators (CRP and SAA) testing, the disease course can be monitored dynamically. The combined detection of antibody, nucleic acid and CRP&SAA can avoid false positive and false negative results, reduce missed diagnosis and prevent the spread of the epidemic. Regarding infectious factors test kits: 1. The company is the first manufacturer to obtain the SAA certificate on the Chinese market. 2. SAA test products of the company are used in more than 1000 hospitals in China. The hospitals for women and children in most provinces of China are the users of the SAA test products of the company. 3. As the first manufacturer in China to promote the SAA testing application in the field of inflammatory infection, the company has rich clinical support and database. 4. SAA test is carried out on all the instrument platforms of the company, which could well match the hospital laboratories of different scales. Regarding cardiac markers test kits: With the time resolved fluorescence based on europium nanoparticles, the sensitivity of the products are higher than the similar products on the market.

Stage of development

CHINA

Partner sought

The Chinese company is looking for distributors in point of care testing area for their 3 kinds of test kits and the matched instruments, namely COVID-19 related test kits, infectious factors test kits and cardiac markers test kits. The Chinese company would like to cooperate with European medical device import companies, foreign trade agencies and other companies with relevant industry marketing experience and distribution resources with medical laboratories, hospitals, drugstores, etc., which can help them to further expand their global sales channels. The distributors are expected to have the acknowledgement of their local markets. They could also offer OEM services for overseas clients. Especially for their COVID-19 related test kits, the company is open for various kinds of collaboration ,including product co-developing, distribution agreement, OEM service.