Anti-cyclic citrullinated peptide antibody assay kit (latex immunoturbidimetry) - NMPA Registration 京械注准20212400528
Access comprehensive regulatory information for Anti-cyclic citrullinated peptide antibody 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 京械注准20212400528 and owned by Beijing Beijian Xinchuangyuan Biotechnology Co., Ltd.. The device was approved on October 18, 2021.
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This product is used for the quantitative determination of anti-cyclic citrullinated peptide antibodies in human serum in vitro.
本产品用于体外定量测定人血清中抗环瓜氨酸肽抗体的含量。
Reagent 1: Tris buffer ge; 50mmol/L PEG6000 ge; 15g/L Reagent 2: Tris buffer ge; 50mmol/L Cyclic citrullinated peptide latex granules GE; 2g/L Calibrator (optional): Bovine serum albumin 20g/L Two levels: Anti-cyclic citrullinated peptide antibody level 1: (0.0~20.0)U/ml Level 2: (80.0~110.0)U/ml Multi-level: Anti-cyclic citrullinated peptide antibody level 1: 0.0 U/ml Level 2: (10.0~20.0) U/ml Level 3: (20.1~40.0) U/ml Level 4: (40.1~80.0) U/ml Level 5: (80.1~110.0) U/ml Quality control (optional): Bovine serum albumin 20g/L Anti-cyclic citrullinated peptide antibody level 1: (15.0~45.0)U/ml Level 2: (45.1~90.0) U/ml There are batch-to-batch differences between calibrators and quality control products, and the specific concentrations are shown in the target value table.
试剂1：Tris缓冲液 ge;50mmol/L PEG6000 ge;15g/L 试剂2：Tris缓冲液ge;50mmol/L 环瓜氨酸肽胶乳颗粒ge;2g/L 校准品（选配）： 牛血清白蛋白20g/L 两水平： 抗环瓜氨酸肽抗体 水平1：(0.0～20.0)U/ml 水平2：(80.0～110.0)U/ml 多水平： 抗环瓜氨酸肽抗体 水平1：0.0U/ml 水平2：(10.0～20.0)U/ml 水平3：(20.1～40.0)U/ml 水平4：(40.1～80.0)U/ml 水平5：(80.1～110.0)U/ml 质控品（选配）： 牛血清白蛋白20g/L 抗环瓜氨酸肽抗体 水平1：(15.0～45.0)U/ml 水平2：(45.1～90.0)U/ml 校准品、质控品有批间差异，具体浓度见靶值表。
2 °C ~ 8 °C protected sealed storage, valid for 12 months.
2℃～8℃避光密封储存，有效期12个月。