The company has passed the high-tech enterprise certification, specialized and special certification and applied for the quality system certification of the Appendix to the Quality Management Specifications for the Production of Medical Devices - In Vitro Diagnostic Reagents. It has the production license for Class I and Class II in vitro diagnostic reagents for medical devices. Now it has obtained: cold typing test kit, early pregnancy test kit, upper and lower gastrointestinal bleeding test kit, qualitative and semi quantitative ovulation test kit 9 Class II medical device registration certificates such as menopause detection, and 17 Class I medical device registration certificates such as medical isolation masks and goggles.
There are more than 160 intellectual property applications, including more than 70 patents and more than 20 invention patents. The company's products sell well on domestic online mainstream platforms and offline pharmacies, clinics and hospitals. Some products are exported to Europe, America, Southeast Asia, Africa and Arab countries. The products have a certain market share at home and abroad.
The company has a total investment of 70 million yuan, covers an area of 23.5 mu, and the existing production site covers more than 18000 square meters. At present, there are more than 3000 square meters of ten thousand and one hundred thousand grade clean areas, 13000 square meters of production and storage areas, 2000 square meters of living quarters, and more than 20 sets of production equipment for intelligent automatic control systems. The company's production efficiency and capacity have always been at a high level in the industry. The production capacity of colloidal gold (early pregnancy, ovulation, COVID-19 antigen detection reagents, etc.) can reach more than 2 million people per day per shift.
The company has colloidal gold, latex, fluorescence immunochromatography, dry chemistry technology platform, intelligent home "cloud" detection platform, and is currently carrying out the application of 7 products (including myocardial infarction prediction detection products, cerebral infarction prediction detection products, gynecological inflammation classification detection products, cough classification detection, diarrhea classification detection, urine occult blood, etc.), of which 3 are national exclusive patents. The company is committed to the research, development and promotion of home self-test products.
