Full-scale C-reactive protein (hs-CRP+ conventional CRP) assay kit (latex immunoturbidimetry) - NMPA Registration 鲁械注准20232401176
Access comprehensive regulatory information for Full-scale C-reactive protein (hs-CRP+ conventional CRP) assay kit (latex immunoturbidimetry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20232401176 and owned by Biobase Biodustry (Shandong) Co., Ltd.. The device was approved on December 20, 2023.
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It is used for in vitro quantitative determination of C-reactive protein content in human serum samples.
用于体外定量测定人血清样本中C反应蛋白的含量。
Main components: Reagent 1 (R1): trismethylolaminomethane (Tris) buffer (pH 7.0) (100mmol/L), PEG6000 (5g/L); Reagent 2 (R2): trimethylolaminomethane (Tris) buffer (pH 7.0) (100mmol/L), CRP antibody (12.8mg/mL), latex particles (10.1%); Calibrator: Calibrator-1 is purified water, and the other calibration solution is C-reactive protein dissolved in phosphate buffer (water matrix), there are 6 concentration levels, and the fixed value is batch specific, see the label for specific values. Control: C-reactive protein dissolved in phosphate buffer at 2 concentration levels, determined to be lot specific, specific target ranges are shown on the label.
主要组成成分： 试剂1（R1）：三羟甲基氨基甲烷（Tris）缓冲液（pH7.0）（100mmol/L）、PEG6000（5g/L）； 试剂2（R2）：三羟甲基氨基甲烷（Tris）缓冲液（pH7.0）（100mmol/L）、CRP抗体（12.8mg/mL）、胶乳颗粒（10.1%）； 校准品：校准液-1为纯化水，其他校准液为C反应蛋白溶于磷酸缓冲液（水基质）中，有6个浓度水平，定值为批特异，具体定值见标签。 质控品：C反应蛋白溶于磷酸缓冲液中，有2个浓度水平，定值为批特异，具体靶值范围见标签。
Store in the dark at 2 °C ~ 8 °C, and have a validity period of 12 months in a non-corrosive gas environment.
避光保存于2℃～8℃，在无腐蚀性气体环境下有效期12个月。