α1-Antitrypsin Test Kit (Immunoturbidimetric Assay) - NMPA Registration 冀械注准20242400327
Access comprehensive regulatory information for α1-Antitrypsin Test Kit (Immunoturbidimetric Assay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 冀械注准20242400327 and owned by Hebei Archi Biological Technology Co., Ltd.. The device was approved on August 14, 2024.
This page provides complete registration details including registrant information, province location (Hebei), 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 for in vitro quantitative detection of α1-antitrypsin (AAT) content in human serum.
用于体外定量检测人体血清中α1-抗胰蛋白酶（AAT）的含量。
试剂1 三羟甲基氨基甲烷 20 mmol/L、聚乙二醇6000 5% 试剂2 三羟甲基氨基甲烷 20mmol/L、羊抗人α1-抗胰蛋白酶抗体 10.0% 校准品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白(BSA) 1%、α1-抗胰蛋白酶 质控品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白(BSA) 1%、α1-抗胰蛋白酶
试剂1 三羟甲基氨基甲烷 20 mmol/L、聚乙二醇6000 5% 试剂2 三羟甲基氨基甲烷 20mmol/L、羊抗人α1-抗胰蛋白酶抗体 10.0% 校准品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白（BSA） 1%、α1-抗胰蛋白酶 质控品 三羟甲基氨基甲烷 20 mmol/L、牛血清白蛋白（BSA） 1%、α1-抗胰蛋白酶
The reagent is stable for 18 months when stored in a closed space at 2-8°C.
试剂2-8℃密闭储存可稳定18个月。