Anti-transparency tape antibody IgG detection reagent kit (chemiluminescence immunoassay) - NMPA Registration 湘械注准20222401979
Access comprehensive regulatory information for Anti-transparency tape antibody IgG detection reagent kit (chemiluminescence 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20222401979 and owned by Changsha Micron Biotechnology Co., Ltd.. The device was approved on October 28, 2022.
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It is used for in vitro qualitative detection of anti-zona pellucida antibody IgG (ZP-IgG) in human serum and plasma samples, and is mainly used clinically for the auxiliary diagnosis of infertility.
用于体外定性检测人血清、血浆样本中抗透明带抗体IgG(ZP-IgG)，临床上主要用于不孕症的辅助诊断。
It consists of R1, R2, reagent M and calibrator (optional). The main components of R1 are: 0.01M 1% BSA dissolved in phosphate buffer; The main components of R2 were: 0.5μg/mL acridine ester-labeled murine anti-human IgG monoclonal antibody dissolved in MES buffer; The main components of reagent M were: 0.4mg/mL magnetic particles conjugated to ZP-IgG antigen dissolved in phosphate buffer; The main components of the calibrator (optional) are: Tris buffer containing ZP-IgG antibodies, where the concentration range of calibrator 1 is: 20RU/mL, and the concentration range of calibrator 2 is: 200RU/mL.
由R1、R2、试剂M及校准品（选配）组成。R1主要成分为：0.01M 1％BSA溶于磷酸盐缓冲液；R2主要成分为：0.5µg/mL吖啶酯标记的鼠抗人IgG单克隆抗体溶于MES缓冲液；试剂M主要成分为：0.4mg/mL偶联 ZP-IgG抗原的磁微粒溶于磷酸盐缓冲液；校准品（选配）主要成分为：含ZP-IgG抗体的Tris缓冲液，其中校准品1浓度范围为：20RU/mL，校准品2浓度范围为：200RU/mL。
The unopened kit is stored in a closed and protected manner at 2~8 °C for 15 months, and it can be stable for 28 days after opening.
未开瓶试剂盒于2～8℃密闭避光保存有效期为15个月，开瓶后2～8℃避光保存可稳定28天。