亮氨酸氨基肽酶测定试剂盒（L-亮氨酸-P-硝基苯胺底物法）
- Device class
- Class II
- Model specifications
- 试剂：1×20mL、试剂：1×50mL、试剂：1×60mL、试剂：2×50mL、试剂：4×50mL、试剂：5×40mL、试剂：1×70mL（400测试/盒，日立LST生化分析仪专用）、试剂：2×70mL（800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20252405404
- Approval date
- January 26, 2025
- Expiry date
- January 25, 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
For in vitro quantitative determination of leucine aminopeptidase activity in human serum.
用于体外定量测定人血清中亮氨酸氨基肽酶的活性。
试剂：Tris缓冲液，L-亮氨酸-P-硝基苯胺。（具体内容详见说明书）
试剂在2℃～8℃避光环境密封保存中的有效期为12个月，严禁冷冻。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 亮氨酸氨基肽酶测定试剂盒（L-亮氨酸-P-硝基苯胺底物法） 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20252405404 and owned by Wuhan Changli BIOTECH Co., Ltd.. The device was approved on January 26, 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.