Homocysteine Detection Reagent Kit (Circulating Enzyme Method)
- Device class
- Class II
- Model specifications
- 试剂1：1×20 mL 试剂2：1×4 mL、 试剂1：2×24 mL 试剂2：1×8 mL、试剂1：1×48 mL 试剂2：1×8 mL、 试剂1：1×54 mL 试剂2：1×9 mL、试剂1：3×28 mL 试剂2：1×14 mL、试剂1：2×42 mL 试剂2：1×14 mL、试剂1：1×84 mL 试剂2：1×14 mL、试剂1：3×32 mL 试剂2：1×16 mL、试剂1：2×48 mL 试剂2：1×16 mL、试剂1：3×38 mL 试剂2：1×19 mL、试剂1：2×57 mL 试剂2：1×19 mL、试剂1：2×84 mL 试剂2：2×14 mL、276测试/盒（日立LST生化分析仪专用）、2×276测试/盒（日立LST生化分析仪专用）、314测试/盒（日立LST生化分析仪专用）、2×314测试/盒（日立LST生化分析仪专用）。
- Approval department
- Hubei Provincial Drug Administration湖北省药品监督管理局
- Registration number
- 鄂械注准20252405377
- Approval date
- January 21, 2025
- Expiry date
- January 20, 2030
- Name
- Wuhan Changli BIOTECH Co., Ltd.武汉市长立生物技术有限责任公司
- Province/Region
- Hubei湖北
- Address
- Room 01, 3rd floor, 4th floor, No. 388, Gaoxin 2nd Road, Wuhan Optics Valley International Biomedical Enterprise Accelerator, Phase 1.1, Phase 10, East Lake New Technology Development Zone, Wuhan武汉市东湖新技术开发区高新二路388号武汉光谷国际生物医药企业加速器1.1期10栋3层01室、4层01室
- Production address
- 武汉市东湖新技术开发区高新二路388号武汉光谷国际生物医药企业加速器1.1期10栋一、三、四层
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。
- Appendix
- 产品技术要求、说明书
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.