25-Hydroxy Vitamin D Assay Kit (Latex Immunoturbidimetric Method) - NMPA Registration 京械注准20232400581
Access comprehensive regulatory information for 25-Hydroxy Vitamin D Assay Kit (Latex Immunoturbidimetric Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20232400581 and owned by Beijing Homa Biological Engineering Co., Ltd.. The device was approved on September 19, 2023.
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This reagent is used for the quantitative determination of the concentration of 25-hydroxyvitamin D [25-OH VD] in human serum in vitro.
本试剂用于体外定量测定人血清中25-羟基维生素D[25-OH VD]的浓度。
This reagent consists of Reagent 1 (R1), Reagent 2 (R2), Calibrator and Quality Control Reagent 1 (R1): TRIS buffer 50 mmol/L MgCL2 100mmol/L Glucose hexaphosphate 0.15mmol/L BSA 5g/L Sodium azide 1g/L Reagent 2 (R2): TRIS buffer 50 mmol/L Latex granule suspension coated with anti-25-hydroxyvitamin D antibody 0.15% BSA 5g/L Sodium azide 1g/L Calibrators (5 levels of liquid, phosphate buffer matrix) with target concentration ranges (level 1:0 ng/mL, level 2:15.0~35.0 ng/mL, level 3:45.0~70.0 ng/mL, level 4: 85.0~115.0 ng/mL, level 5:116.0~155.0 ng/mL). The control (2 levels of liquid, phosphate buffer matrix), the target concentration range was (level 1:10.0~40.0ng/mL, level 2:42.0~110.0ng/mL). Note: 1) Calibrators and quality control products have batch specificity, and the specific concentration is shown on the label. 2) Calibrator traceability: According to the requirements of GB/T 21415-2008 "Metrology traceability of measurement of calibrators and value assignment of control substances in biological samples of in vitro diagnostic medical devices", the source, assignment and measurement uncertainty of the calibrator can be traced to the standard substance (number: NIST SRM972).
本试剂由试剂1（R1）、试剂2（R2）、校准品和质控品组成 试剂1（R1）： TRIS缓冲液 50mmol/L MgCL2 100mmol/L 葡萄糖六磷酸 0.15mmol/L BSA 5g/L 叠氮钠 1g/L 试剂2（R2）： TRIS缓冲液 50mmol/L 包被抗25-羟基维生素D抗体的胶乳颗粒悬浊液 0.15% BSA 5g/L 叠氮钠 1g/L 校准品（5水平液体，磷酸盐缓冲液基质），目标浓度范围分别为（水平1：0 ng/mL、水平2：15.0～35.0 ng/mL、水平3：45.0～70.0 ng/mL、水平4：85.0～115.0 ng/mL、水平5：116.0～155.0 ng/mL）。 质控品（2水平液体，磷酸盐缓冲液基质），目标浓度范围分别为（水平1：10.0～40.0ng/mL、水平2：42.0～110.0ng/mL）。 注：1）校准品、质控品具有批特异性，具体浓度见标签。2）校准品溯源性：按照GB/T 21415-2008《体外诊断医疗器械生物样品中量的测量校准品和控制物质赋值的计量学溯源性》的要求提供校准品的来源、赋值以及测量不确定度等内容，溯源至国际标准物质（编号：NIST SRM972）。
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