Glutathione Reductase Assay Kit (Glutathione Substrate Method) - NMPA Registration 京械注准20232400587
Access comprehensive regulatory information for Glutathione Reductase Assay Kit (Glutathione Substrate 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20232400587 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 glutathione reductase (GR) activity in human serum in vitro.
本试剂用于体外定量测定人血清中谷胱甘肽还原酶(GR)的活性。
This reagent consists of Reagent 1 (R1), Reagent 2 (R2), calibrator, and quality control Reagent 1 (R1): Tris(hydroxymethyl)aminomethane (Tris Ultra Pure) 6.05g/L Hydrochloric acid 0.6ml/L Sodium chloride 5.844g/L Glutathione (GSSG) 0.6g/L Sodium azide 1g/L Reagent 2 (R2): 3-(cyclohexylamine)-2-hydroxy-1-propanesulfonic acid CAPSO free acid 6.05g/L Sodium hydroxide 0.11 g/L Sodium chloride 12.58g/L beta;-nicotinamide adenine dinucleotide phosphate disodium salt (NaDPH-Na) 0.4 g/L Sodium azide 2.0g/L Calibrator (monolevel liquid, phosphate buffered saline matrix) with a target concentration range of (70~200U/L). QCs (2 levels of liquid, phosphate buffered matrix)) with target concentrations ranging from (levels 1:30~70U/L, levels 2:90~200U/L). 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 the source is traced to pure glutathione reductase (source: sigma; purity; purity; 95%).
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）： 三羟甲基氨基甲烷（Tris Ultra Pure） 6.05g/L 盐酸 0.6ml/L 氯化钠 5.844g/L 谷胱甘肽（GSSG） 0.6g/L 叠氮钠 1g/L 试剂2（R2）： 3-(环己胺)-2-羟基-1-丙磺酸 CAPSO 游离酸（CAPSO free acid） 6.05g/L 氢氧化钠 0.11 g/L 氯化钠 12.58g/L beta;-烟酰胺腺嘌呤二核苷酸磷酸二钠盐（NaDPH-Na） 0.4g/L 叠氮钠2.0g/L 校准品（单水平液体，磷酸盐缓冲液基质），目标浓度范围为（70～200U/L）。 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1：30～70U/L、水平2：90～200U/L）。 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，溯源至谷胱甘肽还原酶纯品（来源：sigma；纯度ge;95%）。
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