Composite quality control material for heart failure markers - NMPA Registration 鲁械注准20252400040
Access comprehensive regulatory information for Composite quality control material for heart failure markers in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20252400040 and owned by Shandong Kanghua Biotechnology Co., Ltd.. The device was approved on January 23, 2025.
This page provides complete registration details including registrant information, province location (Shandong), 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.
适用于山东康华生物医疗科技股份有限公司的N末端B型脑钠肽前体（NT-proBNP）测定试剂盒（磁微粒化学发光法）、脑利钠肽（BNP）测定试剂盒（磁微粒化学发光法），青岛汉唐生物科技有限公司的N端-B型钠尿肽前体（NT-proBNP）检测试剂盒（干式免疫荧光法）、B型钠尿肽（BNP）测定试剂盒（免疫荧光法）检测时的质量控制。
质控品（冻干）（水平1、水平2）：含B型脑利钠肽（BNP）合成抗原、N末端B型脑钠肽前体（NT-proBNP）大肠杆菌重组抗原；基质为含牛血清白蛋白的基质液，冻干品。质控品靶值具有批特异性，具体范围见靶值单。
Store at -20°C with a validity period of 12 months.
-20℃条件下储存，有效期12个月。