China NMPA legacy archive 鄂械注准20242405013Cystatin C determination reagent kit (latex immunoturbidimetric method)
胱抑素C测定试剂盒（胶乳免疫比浊法）
Wuhan Life Origin Biotech Joint Stock Co., Ltd.Class IINMPAApproved June 06, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- 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 information
- Registration number
- 鄂械注准20242405013
- Approval date
- June 06, 2024
- Expiry date
- June 05, 2029
Registrant
- Province/Region
- Hubei
- Address
- 1st, 2nd and 3rd floor, No. 818 Gaoxin Avenue, Wuhan East Lake New Technology Development Zone, No. 818 High-tech Medical Equipment Park
湖北
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 facility
- 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
Intended use
English
本品用于体外定量测定人体血清、血浆中胱抑素C的含量。
Structure and composition
English
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）
Storage conditions and expiration
English
This product can be stable for 18 months when stored in a closed and dark manner at 2 °C ~ 8 °C.
中文
本品2℃～8℃密闭避光储存可稳定18个月。
Additional information
- Changes
- 无无
- Appendix
- 产品技术要求、说明书
About this record
This static archive preserves historical registration fields and translations for Cystatin C determination reagent kit (latex immunoturbidimetric method), registration 鄂械注准20242405013. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.