Anti-transparency tape antibody IgG detection reagent kit (chemiluminescence immunoassay)
- Device class
- Class II
- Model specifications
- 100 servings/box, 200 servings/box. Calibrators (optional): 0.5mL×2, 1.0mL×2, 0.5mL×6, 1.0mL×6100人份/盒，200人份/盒。校准品(选配)：0.5mL×2、1.0mL×2、0.5mL×6、1.0mL×6
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20222401979
- Approval date
- October 28, 2022
- Expiry date
- October 27, 2027
- Name
- Changsha Micron Biotechnology Co., Ltd.长沙市微米生物科技有限公司
- Province/Region
- Hunan湖南
- Address
- Room 1001, 1002, 1007, 1008, Standard Factory Building, Shanhe Pharmaceutical and Health Industrial Park, No. 1048, Zhongqing Road, Shaping Street, Kaifu District, Changsha长沙市开福区沙坪街道中青路1048号山河医药健康产业园标准厂房3栋1001、1002、1007、1008房
- Production address
- 长沙市开福区沙坪街道中青路1048号山河医药健康产业园第3栋201房
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。
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.
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.