Heart Fatty Acid Binding Protein Test Kit (Latex-Enhanced Immune Turbidimetry Method) - NMPA Registration 渝械注准20172400120
Access comprehensive regulatory information for Heart Fatty Acid Binding Protein Test Kit (Latex-Enhanced Immune Turbidimetry 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 渝械注准20172400120 and owned by Chongqing Zhongyuan BIO-TECHNOLOGY Co., Ltd.. The device was approved on October 15, 2021.
This page provides complete registration details including registrant information, province location (Chongqing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
It is used to detect the content of central fatty acid-binding protein in human samples (serum, plasma), and is mainly used clinically for the auxiliary diagnosis of acute myocardial infarction.
用于检测人体样本（血清、血浆）中心型脂肪酸结合蛋白的含量，临床上主要用于急性心肌梗死辅助诊断。
Reagent R1 Phosphate buffer 18mmol/L Reagent R2 Latex solution 0.3% cardioid fatty acid-binding protein calibrator Recombinant cardio-fatty acid-binding protein Labeled values are shown in bottle labels The measurement system is traceable to corporate standards. Components in different lot sizes are not interchangeable.
试剂R1 磷酸盐缓冲液 18mmol/L试剂R2 胶乳溶液 0.3%心型脂肪酸结合蛋白校准品重组心型脂肪酸结合蛋白 标示值见瓶签 测定系统可溯源至企业标准。不同批号试剂盒中各组份不能互换。
1. The kit should be stored at 2~8 °C in the dark, and should not be frozen. The product is valid for 12 months. 2. After opening, store at 2~8 °C, can be stable for 30 days, please cover the reagent cover when not in use to avoid contamination. 3. After the control is opened, it can be stored at 2~8 °C and can be stable for 30 days.
1. 试剂盒应2～8℃避光贮存，不得冻存。产品有效期为12个月。2. 开封后，在2～8℃下贮存，可稳定30天，不使用时请盖好试剂盖，避免污染。3.质控品开封后，在2～8℃下贮存，可稳定30天。