Ferritin 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20232400532
- 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 the quantitative determination of ferritin content in human serum or plasma in vitro.
用于体外定量测定人血清或血浆中铁蛋白的含量。
name Composition Loading Reagent M Superparamagnetic particles coated with ferritin antibodies, > 0.1 g/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 1 Anti-ferritin antibody-alkaline phosphatase marker, > 0.1 mg/L Tris buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 2 Sample processing fluid Tris buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 5mL; Serves 100: 10mL Calibrators (Optional) 3 levels, ferritin, stabilizers, preservatives Target Concentration Range: Level 1: 0-10 ng/mL, Level 2: 10-500 ng/mL, Level 3: 500-1500 ng/mL 1mL 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 包被着铁蛋白抗体的超顺磁性微粒,>0.1g/L ProClin 300,0.1% 50人份:3mL; 100人份:6mL 试剂1 抗铁蛋白抗体-碱性磷酸酶标记物,>0.1mg/L Tris缓冲液,50 mmol/L ProClin 300,0.1% 50人份:3mL; 100人份:6mL 试剂2 样本处理液 Tris缓冲液,50mmol/L ProClin 300,0.1% 50人份:5mL; 100人份:10mL 校准品 (选配) 3水平,含铁蛋白,稳定剂,防腐剂 目标浓度范围: 水平1:0-10 ng/mL;水平2:10-500 ng/mL;水平3:500-1500 ng/mL 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
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