Pulposoperoxidase assay kit (latex immunoturbidimetry) - NMPA Registration 京械注准20232400603
Access comprehensive regulatory information for Pulposoperoxidase assay kit (latex immunoturbidimetry) 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20232400603 and owned by Beijing Homa Biological Engineering Co., Ltd.. The device was approved on September 27, 2023.
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This reagent is used for the quantitative determination of the concentration of myeloperoxidase [MPO] in human serum in vitro.
本试剂用于体外定量测定人血清中髓过氧化物酶[MPO]的浓度。
This reagent consists of Reagent 1 (R1), Reagent 2 (R2), Calibrator and Quality Control Reagent 1 (R1): Phosphate buffer 15 mmol/L Sodium azide 1g/L Reagent 2 (R2): TAPS buffer 20 mmol/L Coated anti-MPO antibody latex microspheres 0.2% Sodium azide 1g/L Calibrator (5 levels of liquid, phosphate buffer matrix), the target concentration ranges are (level 1:50~100ng/mL, level 2:130~150ng/mL, level 3:250~340ng/mL, level 4::500~680ng/mL, level 5:900~1300ng/mL). Control (2 levels of liquid, phosphate buffer matrix), target concentration ranges (level 1:50~150 ng/mL, level 2:500~1000 ng/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 are traced to the working calibrators of the enterprise.
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）： 磷酸盐缓冲液 15mmol/L 叠氮钠 1g/L 试剂2（R2）： TAPS缓冲液 20mmol/L 包被抗MPO抗体胶乳微球 0.2% 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1：50～100ng/mL、水平2：130～150ng/mL、水平3：250～340ng/mL、水平4:：500～680ng/mL、水平5：900～1300ng/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1：50～150 ng/mL、水平2：500～1000 ng/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，溯源至企业工作校准品。
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