‘CE’ is a safety certification mark, which is taken as a passport for manufacturers to enter the European market. In European Union market, CE mark is a mandatory certification mark, no matter the product is made within the European Union, or made in other countries, it’s a must to paste CE mark to show that the product meets the basic requirement of the EU directive on new methods of Technical Coordination and Standardization for the free circulation among EU.
CE certificate represents that the Novel Coronavirus Reagent produced by BACME Biotech complies with relevant EU laws and regulations, meanwhile, which meets the EU strict standard in line with product performance and indicators. This is not only the recognition of the quality of our products, but also the affirmation of the R&D strength and management ability on BACME.
BACME Biotech Novel Coronavirus Nucleic Acid test kit and IgM/IgG antibody test kit obtains CE certificate, the name of them are Novel Coronavirus (SARS-CoV-2) RNA Real-Time Kit (PCR- fluorescence) and SARS-CoV-2 IgM/IgG Detection Kit (Colloidal Gold Method). The CE certificate indicates that BACME test kits meet the compliance requirement of the EU medical device directive and meets the access qualification of EU market.
The development and certification of Novel Coronavirus detection product reflects the company's core strategy that taking products as the core and market oriented, focusing on the field of molecular diagnostic testing field, rapidly introducing new products, exploring new markets and achieve the new growth.
At present, the global epidemic situation is still serious, especially in Latin America, which is still on the rise. As the most professional leader in the field of in vitro diagnosis, BACME Biotech will continue to provide high performance Novel Coronavirus detection product and contribute to the global precise prevention and control of the epidemic.