Gastrin 17 Assay Kit (Chemiluminescence Immunoassay)
- Device class
- Class II
- Model specifications
- 100 servings/box, 200 servings/box.100人份/盒、200人份/盒。
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20232401184
- Approval date
- December 11, 2023
- Expiry date
- December 10, 2028
- 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 and 1008 of the standard factory building of Shanhe Pharmaceutical and Health Industrial Park, No. 1048, Zhongqing Road, Shaping Street, Kaifu District, Changsha City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
This product is suitable for the quantitative determination of gastrin 17 (G-17) content in human serum or plasma samples in vitro.
本产品适用于体外定量测定人血清或血浆样本中胃泌素17（G-17）的含量。
The reagent consists mainly of magnetic bead coating (M), biotin marker (R1), acridine ester marker (R2), calibrator (optional) and quality control (optional).
试剂主要由磁珠包被物(M)、生物素标记物(R1)、吖啶酯标记物(R2)、校准品(选配)和质控品(选配)组成。
This reagent is stored at 2~8 °C and the validity period is 12 months. The in-machine stability of the reagent is 28 days. After the reconstitution of the calibrator and quality control product, it is stored at 2~8 °C and the validity period is 7 days.
本试剂于2～8℃保存，有效期为12个月。试剂在机稳定性为28天。校准品、质控品复溶后，于2～8℃保存，有效期为7天。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Gastrin 17 Assay 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20232401184 and owned by Changsha Micron Biotechnology Co., Ltd.. The device was approved on December 11, 2023.
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.