Low density lipoprotein cholesterol test kit (selective clearance method) - NMPA Registration 滇械注准20162400086
Access comprehensive regulatory information for Low density lipoprotein cholesterol test kit (selective clearance method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 滇械注准20162400086 and owned by Yunnan Haoxu Biotechnology Co., Ltd.. The device was approved on September 27, 2021.
This page provides complete registration details including registrant information, province location (Yunnan), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
For in vitro quantitative determination of serum LDL cholesterol
用于血清中低密度脂蛋白胆固醇体外定量测定
"R1: piperazine-1,4-bis(2-ethanesulfonic acid) 50mmol/L, cholesterol lipase (CE) 800U/L, cholesterol oxidase (CO) 400U/L, Tween-80 10ml/L, peroxidase (POD) 1000U/L R2: piperazine-1,4-bis(2-ethanesulfonic acid) (pH 7.0) 50mmol/L, Qutong X-100 10ml/L, 4-aminoantipyrine (4-APP) 1.0mmol/L N-ethyl-N-(3-propanesulfonyl)-3-methylaniline"
"R1：哌嗪-1,4-双(2-乙磺酸) 50mmol/L、胆固醇脂酶（CE）800U/L、胆固醇氧化酶（CO）400U/L、吐温-80 10ml/L、过氧化物酶（POD）1000U/L R2：哌嗪-1,4-双(2-乙磺酸)(pH7.0) 50mmol/L、曲通 X-100 10ml/L、4-氨基安替比林（4-APP）1.0mmol/L N-乙基-N-(3-丙磺基)-3-甲基苯胺"
"The kit is stored at 2~8 °C, and it can be stable for one year in the dark. After opening the reagent, pay attention to avoid contamination, 2~8 °C can be stable for one week, it is recommended to finish as soon as possible. "
"试剂盒贮存在2～8℃下，避光保存可稳定一年。 试剂开瓶后注意避免污染，2～8℃可稳定一周，建议尽快完。 "