C-reactive Protein Test Reagent Kit (Chemiluminescent Immunoassay) - NMPA Registration 湘械注准20222400067
Access comprehensive regulatory information for C-reactive Protein Test Reagent Kit (Chemiluminescent Immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20222400067 and owned by Hunan Huaxi Pharmaceutical Co., Ltd.. The device was approved on January 18, 2022.
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It is used for the quantitative detection of the concentration of C-reactive protein in human serum in vitro.
用于体外定量检测人血清中C反应蛋白的浓度。
Reagent 1: Biotin-labeled C-reactive protein monoclonal antibody (approx. 0.5 mg/L, murine), phosphate buffer (containing 1% bovine serum protein, 0.1% Proclin300, PH7.4); Reagent 2: C-reactive protein monoclonal antibody containing acridine ester (approximately 0.5 mg/L, murine), phosphate buffer (containing 1% bovine serum protein, 0.1% Proclin300, PH7.4); Reagent M: Streptavidin-coated magnetic particles (approximately 0.3 mg/mL) containing 0.1% chloroacetamide; Series calibrators: with C-reactive protein (human), phosphate buffer (with 1% bovine serum protein, 0.1% Proclin300, PH7.4); The concentrations were about 0, 0.5, 5, 20, 50, 100mg/L.
试剂 1:含生物素标记的 C 反应蛋白单克隆抗体(约 0.5mg/L,鼠源性), 磷酸盐缓冲液(含 1%牛血清蛋白,0.1%Proclin300,PH7.4);试剂 2:含吖啶酯标记的 C 反应蛋白单克隆抗体(约 0.5mg/L,鼠源性),磷酸盐缓冲液(含 1%牛血清蛋白,0.1%Proclin300,PH7.4);试剂 M:含链霉亲和素包被的磁颗粒(约 0.3mg/mL),含 0.1% 氯乙酰胺;系列校准品:含 C 反应蛋白(人源性),磷酸盐缓冲液(含 1%牛血清蛋白, 0.1%Proclin300,PH7.4);浓度分别约为:0、0.5、5、20、50、100mg/L。
Store at 2-8°C, valid for 18 months; The opened reagents and calibrators can be stored stably for 60 days at 2-8°C.
2-8℃环境下储存，有效期18个月；开封的试剂及校准品，2-8℃环境下可稳定保存60天。