Gentamicin Assay Kit (Chemiluminescence Immunoassay)
- Device class
- Class II
- Model specifications
- 50 servings/box; 100 servings/box
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20232400531
- Approval date
- September 01, 2023
- Expiry date
- August 31, 2028
- Province/Region
- Beijing
- Address
- 101, 1st to 3rd floor, Building 19, No. 2 Huanke Middle Road, Beijing Economic and Technological Development Zone (Tongzhou), Beijing
- Production address
- 北京市通州区环科中路2号院19号楼-1至3层
It is used for in vitro quantitative determination of gentamicin content in human serum and plasma.
用于体外定量测定人血清、血浆中的庆大霉素含量。
name Composition Loading Reagent M Coated mouse anti-gentamicin monoclonal antibody superparamagnetic particles, > 0.1 g/L Proclin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 1 Gentamicin-alkaline phosphatase marker, > 0.1 mg/L Proclin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 2 Tris buffer, 50 mmol/L Proclin 300,0.1% Serves 50: 8mL; Serves 100: 15mL Calibrators (Optional) 3 levels, lyophilized product, containing gentamicin, stabilizer, preservative Target Concentration Range: S1:0-3micro; g/mL;S2:3-6micro; g/mL;S3:6-14micro; g/mL Reconstitute 1 mL volume Calibration information A QR code containing information about the main calibration curve / Note: Calibrator assignment is batch-specific, and the target value of each lot is detailed in the label.
名称 组成成分 装量 试剂M 包被鼠抗庆大霉素单克隆抗体超顺磁性微粒,>0.1 g/L Proclin 300,0.1% 50人份:3mL; 100人份:6mL 试剂1 庆大霉素-碱性磷酸酶标记物,>0.1mg/L Proclin 300,0.1% 50人份:3mL; 100人份:6mL 试剂2 Tris缓冲液,50mmol/L Proclin 300,0.1% 50人份:8mL; 100人份:15mL 校准品 (选配) 3水平,冻干品,含庆大霉素,稳定剂,防腐剂 目标浓度范围: S1:0-3micro;g/mL;S2:3-6micro;g/mL;S3:6-14micro;g/mL 复溶体积1mL 校准信息 二维码,包含主校准曲线信息 / 注:校准品赋值具有批特异性,每批次靶值详见标签。
The reagents are stored at 2 °C ~ 8 °C
试剂在2℃~8℃条件下存放有
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Gentamicin Assay Kit (Chemiluminescence Immunoassay), registration 京械注准20232400531. 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.