The industry standard for Immunohistochemistry Kits, co-drafted by Maixin, will officially take effect on March 1st this year.

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6 2 月, 2026

On 6 2 月, 2026

Background:

On September 6, 2021, the National Medical Products Administration organized the formulation of the industry standard “Immunohistochemistry Reagent Kits” YY/T 1181—2021, replacing the original YY/T 1181—2010. This standard will be implemented from March 1, 2023!

This standard was proposed by the National Medical Products Administration and is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC 136).

Drafting units of this standard：Beijing Medical Device Testing Institute,Fuzhou Maixin Biotechnology Development Co., Ltd., Agilent Technologies (China) Co., Ltd., Roche Diagnostics Products (Shanghai) Co., Ltd., Xiamen Tongling Biomedical Technology Co., Ltd., Gene Tech (Shanghai) Co., Ltd.,National Institutes for Food and Drug Control. Main drafters of this standard: Bi Chunlei, Yang Qinghai, Liu Jia, Yuan Jun, Guo Jincan, Wang Dong, Sun Nan.