Pure Global AI
China NMPA legacy archive 湘械注准20222401979

Anti-transparency tape antibody IgG detection reagent kit (chemiluminescence immunoassay)

抗透明带抗体IgG检测试剂盒(化学发光免疫分析法)
Changsha Micron Biotechnology Co., Ltd.Class IINMPAApproved October 28, 2022
Static archiveNMPA · legacy registration snapshot
Device classification
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×6
100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 information
Registration number
湘械注准20222401979
Approval date
October 28, 2022
Expiry date
October 27, 2027
Registrant
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 facility
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
Intended use
English

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.

中文

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。

Structure and composition
English

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.

中文

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。

Storage conditions and expiration
English

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.

中文

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。

About this record

This static archive preserves historical registration fields and translations for Anti-transparency tape antibody IgG detection reagent kit (chemiluminescence immunoassay), registration 湘械注准20222401979. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.