Recently, our company successfully passed the initial review and re-examination of the ISO13485:2016 /EN ISO13485:2016 quality system certification by the SGS certification body, and obtained the international ISO13485 quality management system certification issued by the SGS certification body. The acquisition of this certificate is the third time that our company has obtained the international quality system certification after passing the Huaguang certification and ITS (Tianxiang Group) certification.
The ISO13485 standard is the general standard of the international medical device industry, and the domestic medical device industry has always taken the ISO13485 standard as an important basis for quality management system certification. The scope of this certification is mainly the research and development, production and sales of the company's "new crown", "influenza" and other highly pathogenic infectious series of diagnostic reagents. Standardization, scientification, and standardization have once again obtained international recognition, which is conducive to the company's expansion in overseas markets.
About Baibo
Jinan Biotech Co., Ltd. was established in 2003 and is a high-tech enterprise specializing in the research, development, production and sales of in vitro diagnostic reagents. On May 30, 2014, the company was successfully listed on the NEEQ (stock name: BaBio, stock code: 830774), becoming one of the first domestic in vitro diagnostic reagents listed companies after the expansion of the NEEQ. In June 2021, Baibo officially entered the innovation layer of the New Third Board.
The products mainly involve: Virus Transport Medium Series, Sterile and Flocking Swabs series, antigen/antibody rapid diagnosis and detection series, Kitmicrobial reagent/temporal examination reagent series, gynecological detection series, biochemical reagent series, medical equipment/robot series,Other colloidal gold series such as women's pregnancy test series, Helicobacter pylori Igg/igm test kit, Mycoplasma pneumoniae Igm test kit, human rotavirus antigen test kit, etc.
After more than ten years of technology accumulation, innovation and equipment improvement, BaBio has become a deep cultivator in the field of microbiology and is one of the few domestic microbiological reagent manufacturers with two fully automatic production lines. The microbial sample pre-processing system independently developed by Biotechnology has filled the gap in the domestic microbial sample processing field. It has been used in the China Intelligent Manufacturing International Summit Forum and the China Intelligent Industry Innovation and Entrepreneurship Conference, and the "Chuangzhixing" Cup China In Vitro Diagnostic Excellent Innovative Product Contests and other competitions won awards. At the same time, with the global epidemic outbreak in 2020, BaBio has played an important role in the virus sampling and detection products produced by the advantages of many years of professional research, quality management capabilities, and fully automated production equipment during the epidemic.