Anti-Endometrial Antibody IgM Detection Test Kit (Chemiluminescence Immunoassay Method)
- 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.
- Approval department
- Hunan Provincial Drug Administration
- Registration number
- 湘械注准20222402000
- Approval date
- November 01, 2022
- Expiry date
- October 31, 2027
- Province/Region
- Hunan
- Address
- Room 1001, 1002, 1007, 1008, Standard Factory Building, Shanhe Pharmaceutical and Health Industrial Park, No. 1048, Zhongqing Road, Shaping Street, Kaifu District, Changsha
- 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
This kit is used for the in vitro qualitative detection of anti-endometrial antibody IgM (EM-IgM) in human serum and plasma samples, and is mainly used clinically for the auxiliary diagnosis of endometriosis.
本试剂盒用于体外定性检测人血清、血浆样本中抗子宫内膜抗体IgM(EM-IgM),临床上主要用于子宫内膜异位症的辅助诊断。
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 IgM monoclonal antibody dissolved in MES buffer; The main components of reagent M are: 0.4mg/mL magnetic particles conjugated with EM-IgM antigen dissolved in phosphate buffer; The main components of the calibrator (optional) are: Tris buffer containing EM-IgM antibody, 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EM-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EM-IgM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. 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。
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