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Chemirumi HBs Antibody II - PMDA ID 341508_22300AMX01270000_B_01_02

ケミルミ HBs抗体II

Access comprehensive regulatory information for Chemirumi HBs Antibody II (ケミルミ HBs抗体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_22300AMX01270000_B_01_02 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 antibody kit / B型肝炎ウイルス表面抗体キット), 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.

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PMDA Official Data
Bilingual (EN/JP)
IVD
IVD
341508_22300AMX01270000_B_01_02
IVD
IVD
Chemirumi HBs Antibody II
ケミルミ HBs抗体II
PMDA ID: 341508_22300AMX01270000_B_01_02
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Intended Use / 使用目的
English

It is also used to monitor the therapeutic effect. )

日本語 (Japanese)

療効果のモニタリングにも使用されます。)

Device Classification / 分類
Device Type
IVD
Device Class
IVD
Class Name (English)
Hepatitis B virus surface antibody kit
Class Name (日本語)
B型肝炎ウイルス表面抗体キット
Registration Information / 登録情報
PMDA ID
341508_22300AMX01270000_B_01_02
Last Update Date
December 23, 2021
Official Documents
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
Product Names / 製品名
Market Name (English)
Chemirumi HBs Antibody II
Market Name (日本語)
ケミルミ HBs抗体II