Folate 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20232400535
- 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 folic acid content in human serum or plasma.
用于体外定量测定人体血清或血浆中叶酸的含量。
name Composition Loading Reagent M Superparamagnetic particles coated with antibiotin antibody, > 0.1 g/L Tris buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 1 Folate-alkaline phosphatase marker, > 0.1 mg/L MES buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 2 Biotinylated folate-binding proteins MES buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Sample processing solution A Protein lysates Tris buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 3mL Sample Processing Solution B 0.5 M sodium hydroxide solution Serves 50: 3mL; Serves 100: 3mL Calibrators (Optional) 3 levels, containing folic acid, stabilizers, preservatives Target Concentration Range: Level 1: 0-2 ng/mL, Level 2: 2-10 ng/mL, Level 3: 10-30 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 包被着抗生物素抗体的超顺磁性微粒,>0.1g/L Tris缓冲液,50mmol/L ProClin 300,0.1% 50人份:3mL; 100人份:6mL 试剂1 叶酸-碱性磷酸酶标记物,>0.1mg/L MES缓冲液,50 mmol/L ProClin 300,0.1% 50人份:3mL; 100人份:6mL 试剂2 生物素化叶酸结合蛋白 MES缓冲液,50mmol/L ProClin 300,0.1% 50人份:3mL; 100人份:6mL 样本处理液A 蛋白裂解剂 Tris缓冲液,50mmol/L ProClin 300,0.1% 50人份:3mL; 100人份:3mL 样本处理液B 0.5M的氢氧化钠溶液 50人份:3mL; 100人份:3mL 校准品 (选配) 3水平,含叶酸,稳定剂,防腐剂 目标浓度范围: 水平1:0-2 ng/mL;水平2:2-10 ng/mL;水平3:10-30 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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