1. The shortage of nucleic acid detection kits will become a global problem.
2. Chinese IVD enterprises have the ability to go abroad and compete with world-class enterprises.
3, for the market testing reagent chaos, the drug regulatory official action!
Many IVD enterprises have obtained the first batch of foreign certification for their new corona products
So far, the State Administration of Food and Drug Administration has approved 20 out-of-body diagnostic kits in an emergency, including 12 nucleic acid detection reagents and 8 antibody detection reagents.
According to The West China Securities Research Report, the world consumes 500,000 to 700,000 nucleic acid testing kits every day. The shortage of nucleic acid testing kits will become a global problem, while the demand for high-efficiency kits made in China is expected to remain high.
Research report data shows that at least 26 countries have submitted supply orders to China, with more than 15 million kits ordered. “The critical shortage of novel Coronavirus detection kits and PERSONAL protective equipment remains unresolved,” the AMA said in a statement Tuesday.
Recently, a number of IVD enterprise new crown products by the first foreign certification on the market. Among the listed companies, at least 9 listed companies, including Meikang Biotechnology, Peoson Biotechnology, Cape Biotechnology, Anke Biotechnology, Daan Genomics, Wanfu Biotechnology, Mike Biotechnology and Hangzhou Realytech, claim that their products have obtained THE EU CE certification.
AusDiagnostics inc., Roche Diagnostics Inc., Vivacheck Inc., Zhijiang Group LTD., CTK Group LTD. (TGA) and Hollogier Group Inc. (TGA) on Saturday, March 22, according to the Australian Drug Administration (TGA). Hangzhou Otai, Vivacheck and Shanghai Zhijiang are domestic IVD enterprises.
In the United States, according to the official website of THE FDA, the real-time fluorescent RT-PCR kit produced by BGI for the detection of SARS-2019-NCOV has been approved by the FDA and can be officially put into the epidemic prevention and control in the United States. This is the first Chinese product that has passed the FDA’s emergency authorization.
In fact, Chinese IVD enterprises have the ability to go abroad and compete with world-class enterprises.
Hangzhou Realytech has passed THE FDA certification. The novel Coronavirus detection rate is high. Please feel free to contact us if you need to purchase a coronavirus quick detection reagent in large quantities.
Post time: Jul-15-2020