Angiotensin II assay kit (microfluidic immunofluorescence method) - NMPA Registration 苏械注准20222402201
Access comprehensive regulatory information for Angiotensin II assay kit (microfluidic immunofluorescence 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 苏械注准20222402201 and owned by Lansion Biotechnology Co., Ltd.. The device was approved on January 09, 2023.
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It is used for the quantitative detection of angiotensin II content in human plasma samples in vitro.
用于体外定量检测人血浆样本中的血管紧张素Ⅱ含量。
1. Angiotensin II microfluidic reagent chip: 1 test/bag detection chip is composed of shell, blood filter pad, absorbent paper and conductive rubber, the internal reaction chamber of the chip is fixed with AII-BSA antigen complex (effective mass of about 0.3μg/test, of which AII is chemical synthesis and BSA is bovine source), and AII murine monoclonal antibody with fluorescent microspheres fixed in the reaction chamber (effective mass is about 0.2μg/test). 2. Other components: manual, calibration curve (QR code).
1.血管紧张素II微流控试剂芯片：1测试/袋检测芯片由外壳、滤血垫、吸水纸以及导电橡胶组成，芯片内部反应腔固定有AII-BSA抗原复合物（有效质量约0.3μg/测试，其中AII为化学合成，BSA为牛源）、反应腔内点样有荧光微球固定的AII鼠单克隆抗体（有效质量约0.2μg/测试）。2.其他组成：说明书、校准曲线（二维码）。
The chips in the kit are stored in a sealed foil bag at 2°C-8°C for 12 months. The chip after the aluminum foil bag is unpacked can be stable for 1 hour at room temperature (10°C-30°C).
试剂盒中芯片在铝箔袋密封状态下存放于2℃-8℃，有效期12个月。铝箔袋拆封后的芯片，在常温（10℃-30℃）下可稳定1小时。