China NMPA legacy archive 鲁械注准20242401108Fibrinogen (FIB) detection test kit (coagulation method)
- Device class
- Class II
- Model specifications
- FIB 凝血酶试剂:5×2mLFIB 缓冲液:2×12mL; FIB 凝血酶试剂:5×2mLFIB 缓冲液:4×6mL; FIB 凝血酶试剂:5×2mLFIB 缓冲液:2×51mL; FIB 凝血酶试剂:10×1mLFIB 缓冲液:2×12mL; FIB 凝血酶试剂:10×2mLFIB 缓冲液:4×12mL; FIB 凝血酶试剂:10×2mLFIB 缓冲液:8×6mL; FIB 凝血酶试剂:10×2mLFIB 缓冲液:2×25mL; FIB 凝血酶试剂:10×4mLFIB 缓冲液:7×12mL; FIB 凝血酶试剂:10×4mLFIB 缓冲液:2×51mL; FIB 凝血酶试剂:10×5mLFIB 缓冲液:2×51mL; FIB 校准品(选配):1×1.0 mL
- Approval department
- Shandong Provincial Drug Administration
- Registration number
- 鲁械注准20242401108
- Approval date
- December 19, 2024
- Expiry date
- December 18, 2029
- Province/Region
- Shandong
- Address
- No. 699, Yuehe Road, Weifang Economic Development Zone
- Production address
- 潍坊经济开发区古亭街8877号
用于体外定量检测人血浆中纤维蛋白原(FIB)含量.
用于体外定量检测人血浆中纤维蛋白原（FIB）含量。
FIB凝血酶试剂:4-羟乙基哌嗪乙磺酸(13g/L)、凝血酶(125mg/L)、Proclin 300(防腐剂)(1mL/L); FIB缓冲液:咪唑(3.404g/L). FIB校准品(选配)(冻干):纤维蛋白原(靶值批特异,见盒内靶值单)、Proclin 300(防腐剂)(1mL/L).
FIB凝血酶试剂：4-羟乙基哌嗪乙磺酸（13g/L）、凝血酶（125mg/L）、Proclin 300（防腐剂）（1mL/L）； FIB缓冲液：咪唑（3.404g/L）。 FIB校准品（选配）（冻干）：纤维蛋白原（靶值批特异，见盒内靶值单）、Proclin 300（防腐剂）（1mL/L）。
试剂盒2～8℃密封保存,有效期为12个月.
试剂盒2～8℃密封保存，有效期为12个月。
- Appendix
- 产品技术要求、说明书
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