Jiu'an Medical (002432.SZ)'s US subsidiary quadruple inspection and triple inspection products were notified before listing by the US FDA

Zhitongcaijing · 2d ago

Zhitong Financial App News, Jiu'an Healthcare (002432.SZ) announced that the following products of the company's US subsidiary iHealth Labs Inc. (“iHealth America”) have received a pre-marketing notice from the US Food and Drug Administration (FDA):

1. Household kit 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 received the US FDA 510 (K) pre-marketing notice (“quadruple test kit”).

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 the US FDA 510 (K) pre-marketing notice (“triple test kit”).

All of the above products can be sold normally in the US market after receiving pre-marketing notifications.