Japan PMDA registration 530513_20600AMY00224000_A_02_02

Leu series

JP: Leuシリーズ
Japan flagJapan·IVD·IVD·Updated May 18, 2022
Intended use / 使用目的
English
シリーズ構成製品名CD2(Leu-5b)FITCCD2(Leu-5b)PECD3(Leu-4)FITCCD4(Leu-3A)FITCCD5(Leu-1)FITCCD8(Leu-2a)FITCCD8(Leu-2a)PECD11b(Leu-15)PECD16(Leu-11a)FITCCD19(Leu-12)FITCCD19FITCCD19PECD20(Leu-16)PECD56FITCCD56PE抗HLA-DRFITC抗HLA-DRPE
日本語 (Japanese)
シリーズ構成製品名CD2(Leu-5b)FITCCD2(Leu-5b)PECD3(Leu-4)FITCCD4(Leu-3a)FITCCD5(Leu-1)FITCCD8(Leu-2a)FITCCD8(Leu-2a)PECD11b(Leu-15)PECD16(Leu-11a)FITCCD19(Leu-12)FITCCD19FITCCD19PECD20(Leu-16)PECD56FITCCD56PE抗HLA-DRFITC抗HLA-DRPE
Device classification / 分類
Device Type
IVD
Device Class
IVD
Class Name (English)
Class II immunoassay series
Class Name (日本語)
クラスII免疫検査用シリーズ
Registration information / 登録情報
PMDA ID
530513_20600AMY00224000_A_02_02
Last Update Date
May 18, 2022
Official Documents
View PDF (PMDA)
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/日本ベクトン・ディッキンソン株式会社
About this record

Access comprehensive regulatory information for Leu series (Leuシリーズ) in the Japan medical device market through Pure Global AI's free bilingual database. This IVD medical device is registered under PMDA ID 530513_20600AMY00224000_A_02_02 and manufactured by Manufacture and sales/Nippon Becton Dickinson Co., Ltd.. The device information was last updated on May 18, 2022.

This page provides complete registration details including device class (IVD), classification (Class II immunoassay series / クラスII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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