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Fosun Diagnostics Obtains China Approval for SARS-CoV-2 Antigen Test

NEW YORK ─ Shanghai Fosun Pharmaceutical on Thursday announced that China's National Medical Products Administration (NMPA) has granted approval for Fosun Diagnostic's Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold) for COVID-19 screening.

The kit developed by Fosun Diagnostics, a subsidiary of Fosun Pharma, detects the SARS-CoV-2 nucleocapsid antigen in nasopharyngeal swabs within seven days of infection for patients with respiratory and fever symptoms, providing results in 15 minutes.

Fosun Diagnostics has also obtained the CE mark for use of the kit in the European Union and other geographies that accept the designation, and it has registered the test with the Federal Institute for Drugs and Medical Devices (BfArM) in Germany.

Fosun Pharma noted that its COVID-19 test kits have obtained relevant qualifications and certifications for use in the US, European Union, Australia, and other countries and regions.

The NMPA approved Fosun Diagnostics' Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit for emergency use in March 2020.