Cystatin C determination reagent kit (latex immunoturbidimetric method)
- Device class
- Class II
- Model specifications
- 试剂1:50mL×2、试剂2:20mL×1；试剂1:50mL×1、试剂2:10mL×1；试剂1:25mL×1、试剂2:5mL×1；试剂1:50mL×3、试剂2:30mL×1；试剂1:40mL×2、试剂2:16mL×1；试剂1:40mL×2、试剂2:8mL×2；试剂1:50mL×2、试剂2:10mL×2；试剂1:50mL×4、试剂2:40mL×1；试剂1:50mL×4、试剂2:20mL×2；试剂1:60mL×5、试剂2:60mL×1；试剂1:60mL×5、试剂2:20mL×3；试剂1:60mL×6、试剂2:36mL×2；试剂1:90mL×2、试剂2:36mL×1；试剂1:90mL×4、试剂2:72mL×1；试剂1:50mL×5、试剂2:50mL×1；试剂1:100mL×1、试剂2:20mL×1；试剂1:6×75测试/盒、试剂2:6×75测试/盒；试剂1:12×75测试/盒、试剂2:12×75测试/盒；试剂1:1×180测试/盒、试剂2:1×180测试/盒；试剂1:1×360测试/盒、试剂2:1×360测试/盒；试剂1:2×360测试/盒、试剂2:2×360测试/盒；试剂1:4×360测试/盒、试剂2:4×360测试/盒；试剂1:5×435测试/盒、试剂2:5×435测试/盒；试剂1:6×435测试/盒、试剂2:6×435测试/盒。
- Approval department
- Hubei Provincial Drug Administration湖北省药品监督管理局
- Registration number
- 鄂械注准20242405013
- Approval date
- June 06, 2024
- Expiry date
- June 05, 2029
- Name
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.武汉生之源生物科技股份有限公司
- Province/Region
- Hubei湖北
- Address
- 1st, 2nd and 3rd floor, No. 818 Gaoxin Avenue, Wuhan East Lake New Technology Development Zone, No. 818 High-tech Medical Equipment Park武汉东湖新技术开发区高新大道818号高科医疗器械园B11号1楼、2楼、3楼
- Production address
- 武汉东湖新技术开发区高新大道818号高科医疗器械园B11号1楼、3楼
本品用于体外定量测定人体血清、血浆中胱抑素C的含量。
试剂1：三羟甲基氨基甲烷缓冲液、叠氮化钠；试剂2：兔抗人CysC抗体的胶乳颗粒悬浊液。（具体内容详见产品说明书）
This product can be stable for 18 months when stored in a closed and dark manner at 2 °C ~ 8 °C.
本品2℃～8℃密闭避光储存可稳定18个月。
- Changes
- 无无
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Cystatin C determination reagent kit (latex immunoturbidimetric 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20242405013 and owned by Wuhan Life Origin Biotech Joint Stock Co., Ltd.. The device was approved on June 06, 2024.
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.