Anti-ovary antibody IgM test kit (chemiluminescent immunoassay) - NMPA Registration 湘械注准20222401998
Access comprehensive regulatory information for Anti-ovary antibody IgM test kit (chemiluminescent 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20222401998 and owned by Changsha Micron Biotechnology Co., Ltd.. The device was approved on November 01, 2022.
This page provides complete registration details including registrant information, province location (Hunan), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
This kit is used for the in vitro qualitative detection of anti-ovarian antibody IgM (AOA-IgM) in human serum and plasma samples, and is mainly used clinically for the auxiliary diagnosis of autoimmune oophoritis.
本试剂盒用于体外定性检测人血清、血浆样本中抗卵巢抗体IgM（AOA-IgM），临床上主要用于自身免疫性卵巢炎的辅助诊断。
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 IgM monoclonal antibody dissolved in MES buffer; The main components of reagent M are: 0.4mg/mL magnetic particles conjugated with AOA-IgM antigen dissolved in phosphate buffer; The main components of the calibrator (optional) are: Tris buffer containing AOA-IgM antibody, of which calibrator 1 concentration range: 20RU/mL, calibrator 2 concentration range: 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IgM单克隆抗体溶于MES缓冲液；试剂M主要成分为：0.4mg/mL偶联AOA-IgM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AOA-IgM抗体的Tris缓冲液，其中校准品1浓度范围：20RU/mL，校准品2浓度范围：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. Transportation and storage should be carried out under low temperature conditions of 2~8 °C.
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。运输和保存均应在2～8℃低温条件下进行。