On December 29, 2017, the State Administration of Food and Drug Administration issued the "Notice on the adjustment of product attributes and categories of allergens, flow cytometry, immunohistochemistry and in situ hybridization in vitro diagnostic reagents" (No. 226 of 2017) ) Clear: Reagents related to allergies (allergens), including total IgE detection reagents and specific IgE antibody detection reagents, are managed as the second category of medical devices. In vitro diagnostic reagents for flow cytometry are the third category of in vitro diagnostic reagent management products, including: a. Antibody reagents to guide clinical medication; b. Lymphocyte subset analysis kits; c. Antibody reagents with clear diagnostic value ; Other kits are managed as Class II and Class I. For immunohistochemistry and in-situ hybridization in vitro diagnostic reagents, products that are temporarily not managed as medical devices.