Due to the Octylphenol incident, which caused the PEI to stop updating the list for nearly 2 months, it was finally updated again on 6/11. Base on the excellent performance, the SARS-CoV-2 antigen test kit developed by Jinjian passed the German validation. Jinjian is one of the total 16 companies were updated in the said listing.
The Paul-Ehrilich-Institut is a research institution and medical regulatory agency affiliated to the Federal Ministry of Health. It is a WHO cooperation center for quality assurance of blood products and in vitro diagnostic equipment. It has independent Perform functions such as biological product inspection, clinical trial approval, product approval and listing and batch issuance. At the same time, it can also provide scientific suggestions for the drafting and revision of relevant regulations of EU countries, EU and international committees and other organizations.
Jinjian's SARS-CoV-2 antigen test kit has been approved by German PEI, marking that the quality of the product has reached international standards, indicating that our company has reached a new level in terms of production technology, quality inspection, and quality management.
September, 2020: CE certificated.
November 2020: "white list" of the Ministry of Commerce.
December 2020: approved to enter the Japanese market.
February 2021: BfArM whitelist registered
April 2021: Cameroon registered
It is an affordable, easy-to-use SARS-CoV-2 test kit. Rapid antigen tests perform best when the person is tested in the early stages of infection with SARS-CoV-2 when viral load is generally highest. They also may be informative in diagnostic testing situations in which the person has a known exposure to a confirmed case of COVID-19. Rapid antigen tests can be used for screening testing in high-risk congregate settings in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission.