COVID-19 Neutralizing Antibody Test Kits are developed successfully
GEMC Group is a national high-tech enterprise specializing in the research and development, production and sales of POCT rapid diagnosis, it developed the COVID-19 Neutralizing Antibody Test Kits successfully, it can meet the development of COVID-19 vaccine testing purpose.
And currently The company has 15 medical device product registration certificates, 28 record certificates, and 58 products exclusively for export; 7overseas product international registration certificates: CoVID-19 antibody detection reagent and dengue virus antibody detection reagent German registration Certificate; Kyrgyzstan and Tajikistan, registration certificate of epithelial tissue staining solution (under review in Russia and Uzbekistan); early pregnancy test paper registration certificate in the Philippines, Indonesia, Singapore,etc .; enterprise quality management system obtained EU CE certification; early pregnancy, ovulation, hemoglobin, Five CE (announcement) registration certificates for transferrin and fecal occult blood; the US FDA registered and registered more than 50 products (FDA official website can be inquired). The leading products are infectious disease series: mainly including new crown virus, dengue fever, AIDS, hepatitis B hepatitis C, malaria, syphilis, etc .; tumor early detection and early diagnosis series: mainly including special staining diagnostic solution series, fecal occult blood series, etc .; pregnancy and family planning series: Mainly include premature rupture of membranes, early pregnancy, ovulation, BV detection series, etc .; anti-killing gel and biological dressing series: mainly include cavity coupling agent, no-clean hand disinfection gel, wound dressing, etc. The core products all have intellectual property rights such as independently developed invention patents and computer software copyrights.
So the CE registration in German will be done in next months, and then it can sell in EU market, but there is no problem to sell them in Asia