Booming! Xiamen Bodite rapid SARS-COV-2 antigen test card successfully obtained CE1434 certificate!

On December 21, 2021, the RAPID SARS-COV-2 ANTIGEN TEST CARD independently developed and produced by Biotech (Xiamen) Biotechnology Co., Ltd. for personal and family self-testing successfully obtained the IVDD CE1434 certificate certified by the European Union NB agency. This means that the new crown antigen rapid test card can be sold in the EU and countries that recognize EU CE certification, which will help nearly 500 million people in Europe to do a good job in self-monitoring and self-management in the protracted war against the epidemic, and make certain contributions to the fight against the epidemic. contribute.

CE1434 self-test certification is different from the conventional CE self-conformity declaration. It needs to undergo strict technical review and testing of the manufacturer's medical device products by a third-party notified body recognized by the European Union to prove that the product is safe and reliable in clinical performance, and in line with international technology. Certificates can only be issued after indicators are met. CE self-test certification is difficult, long-term, and strict, and it is a test and judgment of the comprehensive strength of the manufacturer. This time, the rapid SARS-COV-2 antigen test card obtained the CE1434 certificate, which is the recognition of Biotech (Xiamen)'s in vitro diagnostic research and development strength, and has far-reaching significance for Biotech to open up the international market.

The rapid SARS-COV-2 antigen test card (for self-test) independently developed by Bodite is a one-step in vitro test based on immune chromatography. features. Previously, the product has been certified by BfArm in Germany, BASG in Australia, FDA in Thailand and Malaysia, and has passed the performance verification of PEI with the highest gold content in Europe. The blessing of CE self-test certification once again reflects that the product's excellent performance and good user experience have been fully recognized to meet the needs of the international market.

Boditai (Xiamen) Biotechnology Co., Ltd. was founded by a team of overseas returnees, specializing in the development and production of diagnostic reagents. The core technical team has gathered a group of doctors, returnees and foreigners. The company has accumulated profound cooperation resources in domestic and foreign medical and health systems, and has established long-term and stable cooperation channels in many overseas countries. The company has nearly 3,000 square meters of factory buildings, and the 100,000-level clean and dust-free workshop strictly implements ISO13485:2016 and GMP requirements. The production adopts a fully automated production line, high-efficiency production technology and strict quality control. The current daily production capacity reaches 2 million to 3 million pieces. At present, a variety of new crown detection reagents have been developed, forming a nucleic acid + antibody + antigen product matrix and a comprehensive new crown detection solution to meet the needs of detection and prevention at all levels in the global market. With high quality, competitive price and excellent service, Bodite (Xiamen) has supplied this product to many countries and got good customer feedback in the global market.

Boditai is committed to the life and health industry, constantly showing the world the brand strength of independent research and development, innovative development, constantly optimizing the solution to the new crown epidemic, contributing to the construction of a global anti-epidemic firewall, and contributing to human health!

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