Vitamin B12 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20232400533
- 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 in vitro quantitative determination of vitamin B12 content in human serum or plasma.
用于体外定量测定人体血清或血浆中维生素B12的含量。
name Composition Loading capacity Reagent M Superparamagnetic particles coated with VB12 antibody > 0.1 g/L ProClin 300,0.1% Serving 50: 3mL; Serving 100: 6 mL Reagent 1 Intraporcine factor-alkaline phosphatase marker, > 0.1 mg/L ProClin 300,0.1% Serving 50: 3mL; Serving 100: 6 mL Sample treatment solution A Tris buffer, 50 mmol/L ProClin 300,0.1% Serving 50: 3mL; Serving 100: 6 mL Sample treatment solution B NaCl saline solution Serving 50: 3mL; Serving 100: 6 mL Calibrator (Optional) 3 levels, contains human vitamin B12, stabilizer, preservative Target concentration range: Level 1: 0-50 pg/mL; Level 2: 50-1000 pg/mL; Level 3: 1000-5000 pg/mL 1mL Calibration information QR code containing the main calibration curve information / Note: Calibrator assignments are lot-specific, and target values for each lot are detailed on the label.
名称 组成成分 装量 试剂M 包被着VB12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 猪内因子-碱性磷酸酶标记物,>0.1mg/L ProClin 300,0.1% 50人份:3mL; 100人份:6mL 样本处理液A Tris缓冲液,50mmol/L ProClin 300,0.1% 50人份:3mL; 100人份:6mL 样本处理液B NaCl盐溶液 50人份:3mL; 100人份:6mL 校准品 (选配) 3水平,含人维生素B12,稳定剂,防腐剂 目标浓度范围: 水平1:0-50pg/mL;水平2:50-1000 pg/mL;水平3:1000-5000 pg/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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