China NMPA legacy archive 皖械注准20232400057Golgi Protein 73 Detection Reagent Kit (Latex Enhanced Immune Turbidimetry)
- Device class
- Class II
- Model specifications
- R1:1×15ml、R2:1×5ml;R1:4×60ml、R2:2×40ml;R1:2×40ml、R2:2×10ml;R1:1×30ml、R2:1×10ml;R1:4×60ml、R2:4×20ml;R1:2×60ml、R2:1×30ml;R1:1×45ml、R2:1×15ml;R1:4×30ml、R2:4×10ml;R1:2×60ml、R2:2×15ml;R1:1×60ml、R2:1×20ml;R1:1×40ml、R2:1×10ml;R1:2×80ml、R2:2×20ml;R1:2×30ml、R2:2×10ml;R1:1×60ml、R2:1×15ml;R1:4×60ml、R2:4×15ml;R1:2×45ml、R2:2×15ml;R1:1×80ml、R2:1×20ml;R1:4×60ml、R2:2×30ml;R1:2×60ml、R2:2×20ml;R1:1×20ml、R2:1×5ml;R1:4×40ml、R2:4×20ml;R1:1×60ml、R2:1×22ml;R1:1×60ml、 R2:1×17ml;R1:2×60ml、R2:2×17ml;R1:2×60ml、R2:2×22ml;R1:12×60ml、R2:3×60ml;300测试;360测试;600测试;720测试. 校准品规格(选配): 5×0.5ml 6×0.5ml 1×1ml 5×1ml 质控品规格(选配):1×0.5ml 1×1ml 2×0.5ml 2×1ml
- Approval department
- Anhui Provincial Drug Administration
- Registration number
- 皖械注准20232400057
- Approval date
- March 29, 2023
- Expiry date
- March 28, 2028
- Province/Region
- Anhui
- Address
- Anhui Province Hefei City Economic Development District Taohua Industrial Park prosperous Avenue Industrial Investment Liheng Industrial Plaza B12C
- Production address
- 安徽省合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
It is used for the quantitative detection of Golgi protein 73 (GP73) content in human serum in vitro, and is not used for the auxiliary diagnosis of liver cancer.
用于体外定量检测人血清中高尔基体蛋白73(GP73)的含量，不用于肝癌的辅助诊断。
Reagent 1 (R1): phosphate buffer 100 mmol/L; Reagent 2 (R2): phosphate buffer 100mmol/L, murine anti-human Golgi protein 73 monoclonal antibody latex granules 1.5%; Calibrator (optional): Golgi protein 73, phosphate buffer; Quality control (optional): Golgi protein 73, phosphate buffer.
试剂1（R1）：磷酸盐缓冲液100mmol/L； 试剂2（R2）：磷酸盐缓冲液100mmol/L、鼠抗人高尔基体蛋白73单克隆抗体胶乳颗粒1.5%； 校准品（选配）：高尔基体蛋白73、磷酸盐缓冲液； 质控品（选配）：高尔基体蛋白73、磷酸盐缓冲液。
Reagents, calibrators and quality controls can be stable for 18 months when stored in the dark at 2 °C ~ 8 °C to prevent freezing; After opening, it can be stable for 30 days when stored at 2 °C ~ 8 °C.
试剂、校准品、质控品于2℃～8℃避光贮存可稳定18个月，防止冷冻；开瓶后于2℃～8℃贮存可稳定30天。
- Appendix
- 产品技术要求、说明书
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