Jiu'an Medical announced on December 14, 2025, Beijing time. On December 13, 2025, Beijing time, the company's US subsidiary iHealth Labs Inc. has received a pre-marketing notice from the US Food and Drug Administration: 1. Household kits for quadruple testing of influenza A, influenza B, COVID-19 and RSV respiratory syncytial virus; professional kits for quadruple testing of influenza A, influenza B, COVID-19 and RSV respiratory syncytial virus have received a pre-marketing notice from the US FDA 510. 2. Household kit for triple testing of influenza A, influenza B and COVID-19 viruses; professional kits for triple testing of influenza A, influenza B and COVID-19 viruses received pre-marketing notice from the US FDA 510. All of the above products can be sold normally in the US market after receiving pre-marketing notifications.

Zhitongcaijing · 2d ago
Jiu'an Medical announced on December 14, 2025, Beijing time. On December 13, 2025, Beijing time, the company's US subsidiary iHealth Labs Inc. has received a pre-marketing notice from the US Food and Drug Administration: 1. Household kits for quadruple testing of influenza A, influenza B, COVID-19 and RSV respiratory syncytial virus; professional kits for quadruple testing of influenza A, influenza B, COVID-19 and RSV respiratory syncytial virus have received a pre-marketing notice from the US FDA 510. 2. Household kit for triple testing of influenza A, influenza B and COVID-19 viruses; professional kits for triple testing of influenza A, influenza B and COVID-19 viruses received pre-marketing notice from the US FDA 510. All of the above products can be sold normally in the US market after receiving pre-marketing notifications.