Jinan Babio Biotechnology Co., Ltd. recently received an official notification from the EU Notified Body for its self-tested novel coronavirus antigen detection product, and subsequently obtained the CE certification issued by PCBC.

Authentication basic information

 

Chinese Name：新型冠状病毒（2019-nCoV）抗原检测试剂盒（胶体金法）

English Name：SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method)

Product category：IVDD for Self-testing

Certificate Number：1434-IVDD-071/2021。

Certificate validity period：2022.3.30 – 2025.5.27

A hurricane from Europe and the United States to the world

 

As a rapid test product, colloidal gold new crown antigen self-test reagent does not rely on professional equipment and professionals, and non-professionals can operate and interpret it by themselves only with the instructions. In addition to being applicable to scenarios such as community quick inspection, quick inspection, fast pass verification, and daily self-inspection by special staff, the big market is based on personal purchases and home self-examination requirement. With the implementation of local policies, the market size has been further optimized

 

Since the end of 2020, star from the United Kingdom, Germany and the United States, many countries have begun to promote and use the COVID-19 self-testing products for self-detection prevention. As of March 4, 2022, except China, the self-testing products for COVID-19 have covered most countries and regions in the world.

 

To ensure the accuracy of the test, China has strictly prohibited the use of self-test products. On March 4, 2022, marked by the State Food and Drug Administration's first approval of the registration of 4 companies' COVID-19 antigen colloidal gold self-testing agents, domestic preparations are limited to cautiously try to use antigen self-testing products in some high-risk areas. Although whether the use of COVID-19 self-test products will be fully liberalized in the future, and what measures will be introduced by the country, it is still unclear on the policy side. But so far, 21 domestic manufacturers have obtained the COVID-19 self-test antigen certificate.

                 

2021 is the peak of demand for global self-test products. Due to the difficulty of obtaining certification and various congestion, few Chinese companies have obtained effective certification in the early days. Now we can see that the companies which got certification in early day obtained a huge profit and the attention of global investors.

 

Babio biotechnology Co., ltd is one of the early companies seeking to obtain the COVID-19 antigen self-test version product in the EU. Currently it has passed EU certification but missed the golden moment.

 

As an in vitro diagnostic company, the R&D cycle, clinical cycle, certification cycle, quality system, etc. should not be considered impetuous. "Slow is fast" is the truth in this field. The process of certification is a process of continuous accumulation of technology, research and development, production capacity, and craftsmanship. But now, Babio Biotechnology is ready to join this huge industry battle.