Immune multiple composite quality control product - NMPA Registration 粤械注准20232401744
Access comprehensive regulatory information for Immune multiple composite quality control product in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20232401744 and owned by Labnovation Technologies,inc.. The device was approved on October 26, 2023.
This page provides complete registration details including registrant information, province location (Guangdong), 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 in conjunction with the immunofluorescence kit produced by the company for in-house quality control of N-terminal brain natriuretic peptide precursor, D-dimer, cardiac troponin I, creatine kinase isoenzyme, myoglobin, C-reactive protein, serothyoid amylin A, interleukin 6 and procalcitonin.
与本公司生产的免疫荧光试剂盒配套使用，用于N末端脑钠肽前体、D-二聚体、心肌肌钙蛋白I、肌酸激酶同工酶、肌红蛋白、C-反应蛋白、血清样淀粉蛋白A、白介素6和降钙素原检测项目的室内质量控制。
The main components are N-terminal brain natriuretic peptide precursor antigen, D-dimer antigen, cardiac troponin I antigen, creatine kinase isoenzyme antigen, myoglobin antigen, C-reactive protein antigen, serothyoid amylin A antigen, interleukin 6 antigen, procalcitonin antigen, fetal bovine serum, Proclin300 and mannitol.
主要成分为N末端脑钠肽前体抗原、D-二聚体抗原、心肌肌钙蛋白I抗原、肌酸激酶同工酶抗原、肌红蛋白抗原、C-反应蛋白抗原、血清样淀粉蛋白A抗原、白介素6抗原、降钙素原抗原、胎牛血清、Proclin300和甘露醇。
1. Expiration date: The unopened bottle of the control is stored at 2-8°C and has an expiration date of 24 months; 2. After opening the bottle for reconstitution, the stable period of storage and 2-8 °C is 10 days, please use it before the expiration date indicated in the kit.
1.有效期：未开瓶的质控品在2-8℃下贮存，有效期为24个月； 2.开瓶复溶后，储存与2-8℃的稳定期为10天，请在试剂盒表示的失效日期前使用。