Determination kit for lipoprotein C3 (immunoturbidimetric method) - NMPA Registration 皖械注准20212400369
Access comprehensive regulatory information for Determination kit for lipoprotein C3 (immunoturbidimetric method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 皖械注准20212400369 and owned by Anhui Century Kangda Biotechnology Co., Ltd.. The device was approved on November 08, 2021.
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It is suitable for the quantitative determination of apolipoprotein C3 content in human serum in vitro.
适用于体外定量测定人血清中载脂蛋白C3的含量。
R1 Trimethylolaminomethane buffer 10 mmol/L Sodium chloride 0.15mol/L Polyethylene glycol 5.0% R2 Trimethylolaminomethane buffer 10 mmol/L Sheep anti-human apolipoprotein C3 antibody 65% The calibrator is lyophilized powder (optional) consisting of apolipoprotein C3 and bovine serum albumin. The low value of the control (optional), the high value of the control (optional) is lyophilized powder made of apolipoprotein C3 and bovine serum Albumin composition.
R1 三羟甲基氨基甲烷缓冲液 10mmol/L 氯化钠 0.15mol/L 聚乙二醇 5.0% R2 三羟甲基氨基甲烷缓冲液 10 mmol/L 羊抗人载脂蛋白 C3 抗体 65% 校准品为冻干粉（选配）由载脂蛋白 C3、牛血清白蛋白组成。 质控品低值（选配）、质控品高值（选配）为冻干粉由载脂蛋白 C3、牛血清 白蛋白组成。
Unopened reagents should be stored at 2 °C ~ 8 °C in the dark, and the validity period is 12 months. The opened reagent was stored at 2 °C ~ 8 °C in the dark and stable for 28 days. Unopened calibrators, unopened calibrators, and quality control products are sealed and protected from light at 2 °C ~ 8 °C, and the validity period is 12 months. After reconstitution of calibrators and quality control products, they are stored at 2 °C ~ 8 °C in the dark and stable for 5 days.
未开启的试剂应在2℃～8℃避光保存，有效期为12个月。 开启的试剂在2℃～8℃避光保存，稳定28天。 未开启的校准品、未开启的校准品、质控品在2℃～8℃密封避光保存，有效期为12个月。 校准品、质控品复溶后在2℃～8℃避光保存，稳定5天。