Chemirumi HBs Antigen II - PMDA ID 341508_22500AMX00897000_B_01_03
Access comprehensive regulatory information for Chemirumi HBs Antigen II (ケミルミ HBs抗原II) in the Japan medical device market through Pure Global AI's free bilingual database. This IVD medical device is registered under PMDA ID 341508_22500AMX00897000_B_01_03 and manufactured by Manufacture and sales / Siemens Healthcare Diagnostics Co., Ltd.. The device information was last updated on December 23, 2021.
This page provides complete registration details including device class (IVD), classification (Hepatitis B virus surface antigen kit / Ｂ型肝炎ウイルス表面抗原キット), manufacturer information (English and Japanese), intended use, and regulatory compliance data from the official Japan PMDA medical device database. Pure Global AI offers free bilingual access to Japan's complete medical device registry, helping global MedTech companies navigate PMDA regulations efficiently.
You can use the detection reagent that you have, but if it is negative, it is recommended to confirm it by a method with higher detection sensitivity.
いた検出試薬でも使用できますが、陰性化した場合はより検出感度の高い方法で確認することをお奨めします。