Homocysteine Detection Reagent Kit (Circulating Enzyme Method) - NMPA Registration 鄂械注准20252405377
Access comprehensive regulatory information for Homocysteine Detection Reagent Kit (Circulating Enzyme 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 鄂械注准20252405377 and owned by Wuhan Changli BIOTECH Co., Ltd.. The device was approved on January 21, 2025.
This page provides complete registration details including registrant information, province location (Hubei), 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.
用于定量检测人血清或血浆中同型半胱氨酸的含量，临床上主要用于高同型半胱氨酸血症的辅助诊断及心血管病风险的评价。
试剂1：乳酸脱氢酶，丝氨酸（SER），还原性辅酶Ⅰ（NADH），Proclin300。试剂2：胱硫醚-β-合成酶（CBS），胱硫醚-β-裂解酶（CBL），Proclin300。（具体内容详见说明书）
The validity period of the reagent in a sealed environment at 2 °C ~ 8 °C is 12 months.
试剂在2℃～8℃避光环境密封保存中的有效期为12个月。