Fibrinogen (FIB) detection test kit (coagulation method) - NMPA Registration 鲁械注准20242401108
Access comprehensive regulatory information for Fibrinogen (FIB) detection test kit (coagulation 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 鲁械注准20242401108 and owned by Shandong Kanghua Biotechnology Co., Ltd.. The device was approved on December 19, 2024.
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.
用于体外定量检测人血浆中纤维蛋白原(FIB)含量.
用于体外定量检测人血浆中纤维蛋白原（FIB）含量。
FIB凝血酶试剂:4-羟乙基哌嗪乙磺酸(13g/L)、凝血酶(125mg/L)、Proclin 300(防腐剂)(1mL/L); FIB缓冲液:咪唑(3.404g/L). FIB校准品(选配)(冻干):纤维蛋白原(靶值批特异,见盒内靶值单)、Proclin 300(防腐剂)(1mL/L).
FIB凝血酶试剂：4-羟乙基哌嗪乙磺酸（13g/L）、凝血酶（125mg/L）、Proclin 300（防腐剂）（1mL/L）； FIB缓冲液：咪唑（3.404g/L）。 FIB校准品（选配）（冻干）：纤维蛋白原（靶值批特异，见盒内靶值单）、Proclin 300（防腐剂）（1mL/L）。
试剂盒2～8℃密封保存,有效期为12个月.
试剂盒2～8℃密封保存，有效期为12个月。