"Novel Coronavirus (2019-nCoV) Antigen Test Kit (Colloidal Gold)", declared by Zhongshan Bio-Tech Co Ltd, was approved for registration by the National Medical Products Administration on December 11, becoming Zhongshan's first and Guangdong's sixth antigen test kit product to receive the registration certificate for category-3 medical devices.
The newly approved antigen test kit, coming in four specifications, can be kept at 2 to 30 degrees Celsius for 18 months.
Founded in 1991 and located at National Health Technology Park in Zhongshan's Torch Development Zone, Zhongshan Bio-Tech mainly engages in the development of various virus detection kits. Since the COVID-19 outbreak in 2020, the company urgently developed a series of COVID-19 test kits. Its products are sold in Japan, Indonesia, Myanmar, Nepal, Mexico and Bulgaria as well as Hong Kong and Macao.
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