Angiotensin-converting enzyme assay kit (FAPGG substrate method) - NMPA Registration 京械注准20232400606
Access comprehensive regulatory information for Angiotensin-converting enzyme assay kit (FAPGG 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20232400606 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 to quantitatively determine the activity of angiotensin-converting enzyme [ACE] in human serum in vitro.
本试剂用于体外定量测定人血清中血管紧张素转化酶[ACE]的活性。
This reagent consists of a reagent (R1), a calibrator, and a quality control Reagent (R1): Tris buffer 100 mmol/L N-[3-(2-furyl)acryloyl]-L-phenylalacrynoylglycylglycyl 10mmol/L TritonX-100 0.05% Sodium azide 1g/L Calibrator (single-level liquid, phosphate buffered matrix) with a target concentration range of 40~90U/L; Quality control (2 levels of liquid, phosphate buffered saline matrix) with target concentration ranges of (level 1:30~70 U/L, level 2:80~120 U/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 traced back to the calibrators of the enterprise.
本试剂由试剂（R1）、校准品和质控品组成 试剂（R1）： Tris缓冲液 100mmol/L N-[3-(2-呋喃基）丙烯酰]-L-苯丙氨酰甘氨酰甘氨酸 10mmol/L TritonX-100 0.05% 叠氮钠 1g/L 校准品（单水平液体，磷酸盐缓冲液基质），目标浓度范围为40～90U/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1：30～70 U/L、水平2：80～120U/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，溯源至企业工作校准品。
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