Serum Amyloid A Assay Kit (latex immunoturbidimetry) - NMPA Registration 京械注准20212400529
Access comprehensive regulatory information for Serum Amyloid A 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20212400529 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 serum amyloid A (SAA) content in human serum in vitro.
本产品用于体外定量测定人血清中血清淀粉样蛋白A（SAA）的含量。
Reagent 1: Tris buffer ge; 50mmol/L PEG6000ge; 15g/L Reagent 2: Tris buffer ge; 50mmol/L Anti-SAA antibody latex granules ge;0.25% Calibrator (optional) Bovine serum albumin 20 g/L Serum amyloid A level 1: (0.0~5.0) mg/L Level 2: (6.0~19.0)mg/L Level 3: (20.0~45.0)mg/L Level 4: (46.0~95.0)mg/L Level 5: (96.0~130.0)mg/L Quality control (optional) Bovine serum albumin 20g/L Serum amyloid A level 1: (5.0~30.0)mg/L Level 2: (30.1~100.0)mg/L 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 PEG6000ge;15g/L 试剂2：Tris缓冲液 ge;50mmol/L 抗SAA抗体胶乳颗粒ge;0.25% 校准品（选配） 牛血清白蛋白 20g/L 血清淀粉样蛋白A 水平1：(0.0～5.0)mg/L 水平2：(6.0～19.0)mg/L 水平3：(20.0～45.0)mg/L 水平4：(46.0～95.0)mg/L 水平5：(96.0～130.0)mg/L 质控品（选配） 牛血清白蛋白20g/L 血清淀粉样蛋白A 水平1：(5.0～30.0)mg/L 水平2：(30.1～100.0)mg/L 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。