Recently, Shanghai Kehua Bio-Engineering Co.Ltd(002022) released the announcement that the product has obtained the medical device registration certificate. The novel coronavirus (2019 ncov) antigen detection kit (colloidal gold method) developed by the company has been officially listed with the approval of the State Food and Drug Administration (Registration Certificate No.: gxzz 20223400568). As a local enterprise in Shanghai, Shanghai Kehua Bio-Engineering Co.Ltd(002022) actively responded to the national self-test policy and contributed to the fight against the epidemic and the national screening.
It is understood that the Shanghai Kehua Bio-Engineering Co.Ltd(002022) novel coronavirus (2019 ncov) antigen detection kit (colloidal gold method) has the following characteristics: 1 The results are fast. Compared with nucleic acid, covid-19 antigen can be detected in 15 minutes; 2. Convenient detection. Sampling only needs to go deep into the nasal cavity for about 1.5cm, which greatly reduces discomfort and improves the success rate of sampling; 3. Wide applicability. It can be used in hospital or at home to avoid the tedious waiting in line at the hospital and the risk of crowd exposure.
As one of the few established in vitro diagnostic enterprises with a history of 40 years in China, in addition to being widely praised for biochemical immune products, Shanghai Kehua Bio-Engineering Co.Ltd(002022) has more than 20 years of R & D and production experience in the field of POCT colloidal gold detection, among which colloidal gold HIV products are the first Chinese manufacturer to enter the WHO procurement catalogue.
As early as may 2021, Shanghai Kehua Bio-Engineering Co.Ltd(002022) has passed the EU CE certification of covid-19 antigen colloidal gold products by TGS (technogenetics), a holding subsidiary in Italy, and entered the procurement white list of China Medical Insurance chamber of Commerce. The products can be widely used in most parts of the world and play an important role in epidemic prevention and control and management of local governments. (Zhao Ping)
