The English name of the antigen detection kit is: WANTAI SARS-CoV-2 Ag Rapid Test (Colloidal Gold))
Development:
On March 16, 2022, the State Drug Administration (SDA) issued a notice formally approving Wuhan Mind Bio-technology Company Limited's new coronavirus ( 2019-nCoV) antigen detection kit (colloidal gold method) for registration. from March 18, the product will be officially sold through pharmaceutical distribution channels, offline pharmacies and online e-commerce platforms and other channels.
In May 2022, Corfu Medical announced that the new coronavirus antigen detection kit (colloidal gold method) received CE certification from the European Union.
In May 2022, "Sanzang Bio New Coronavirus Antigen Detection Kit (Colloidal Gold Method)" independently researched and developed by Hebei Sanzang Biotechnology Co., Ltd. obtained CE certification of the European Union, and can be sold in the 27 member states of the European Union and other regions that recognize CE certification.
On August 17, 2022, the Medical Devices and In Vitro Diagnostics Subcommittee of the Ministry of Health, Labor and Welfare (MHLW) of Japan agreed to guidelines for allowing online sales of the Neo-Collagen Antigen Test Kit. The MHLW notified local governments of the contents the same day. The approach is for each manufacturer to apply to the central government for approval of the product, and then sell it on the Internet after approval is granted.
In December 2022, the Neocoronavirus antigen detection kit (colloidal gold method) was approved for marketing.