China NMPA legacy archive 湘械注准20232401185γ-Interferon Detection Kit (Chemiluminescence Immunoassay)
- Device class
- Class II
- Model specifications
- 100 servings/box, 200 servings/box.
- Approval department
- Hunan Provincial Drug Administration
- Registration number
- 湘械注准20232401185
- Approval date
- December 11, 2023
- Expiry date
- December 10, 2028
- 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 product is suitable for the quantitative determination of γ-interferon (γ-IFN) 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γ-干扰素（γ-IFN）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
This static archive preserves historical registration fields and translations for γ-Interferon Detection Kit (Chemiluminescence Immunoassay), registration 湘械注准20232401185. 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.