Creatine kinase isoenzyme assay kit (latex immunoturbidimetry) - NMPA Registration 京械注准20232400588
Access comprehensive regulatory information for Creatine kinase isoenzyme 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20232400588 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 creatine kinase isoenzyme (CKMB) concentration in human serum or plasma in vitro.
本试剂用于体外定量测定人血清或血浆中肌酸激酶同工酶（CKMB）的浓度。
This reagent consists of Reagent 1 (R1), Reagent 2 (R2), calibrator, and quality control Reagent 1 (R1): HEPES buffer 20 mmol/L Polyethylene glycol 6000 1.2% Sodium chloride 100mmol/L Sodium azide 1g/L Reagent 2 (R2): TAPS 20mmol/L Coated with anti-creatine kinase isoenzyme MB (CKMB) antibody latex microspheres 0.18% Sodium azide 1g/L Calibrators (6 levels of liquid, phosphate buffer matrix) with target concentration ranges of (level 1: 0 ng/mL, level 2: 5 ~ 20 ng/mL, level 3: 20 ~ 40 ng/mL, level 4: 40 ~ 70 ng/mL, level 5: 80 ~ 130 ng/mL, level 6: 150 ~ 220 ng/mL). Quality control (2 levels of liquid, phosphate buffer matrix) with target concentration ranges of (level 1:5~21ng/mL, level 2:37~133ng/mL). Note: 1) The calibrators and quality controls are batch-specific, and the specific concentrations are shown on the label. 2) Traceability of calibrators: In accordance with the requirements of GB/T 21415-2008 "Metrology Traceability of Measurement Calibrators and Assignment of Control Substances in Biological Samples of In Vitro Diagnostic Medical Devices", the source, assignment and measurement uncertainty of calibrators are provided and traced back to the 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）： HEPES缓冲液 20mmol/L 聚乙二醇6000 1.2% 氯化钠 100mmol/L 叠氮钠 1g/L 试剂2（R2）： TAPS 20mmol/L 包被抗肌酸激酶同工酶MB（CKMB）抗体胶乳微球0.18% 叠氮钠 1g/L 校准品（6水平液体，磷酸盐缓冲液基质），目标浓度范围分别为（水平1：0ng/mL、水平2：5～20ng/mL、水平3：20～40ng/mL、水平4：40～70ng/mL、水平5：80～130ng/mL、水平6：150～220ng/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1：5～21ng/mL、水平2：37～133ng/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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