Japan PMDA registration 341508_21600AMY00004000_E_01_03

Chemirumi IM IgM-HBc Antibody

JP: ケミルミ IM IgM-HBc抗体
Japan flagJapan·IVD·IVD·Updated December 23, 2021
Intended use / 使用目的
English
■■ Principle of measurement
日本語 (Japanese)
■■ 測測定定原原理理
Device classification / 分類
Device Type
IVD
Device Class
IVD
Class Name (English)
Class III immunoassay series
Class Name (日本語)
クラスIII免疫検査用シリーズ
Registration information / 登録情報
PMDA ID
341508_21600AMY00004000_E_01_03
Last Update Date
December 23, 2021
Official Documents
View PDF (PMDA)
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/シーメンスヘルスケア・ダイアグノスティクス株式会社
About this record

Access comprehensive regulatory information for Chemirumi IM IgM-HBc Antibody (ケミルミ IM IgM-HBc抗体) in the Japan medical device market through Pure Global AI's free bilingual database. This IVD medical device is registered under PMDA ID 341508_21600AMY00004000_E_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 (Class III immunoassay series / クラスIII免疫検査用シリーズ), 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.

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