Pure Global

Leu series - PMDA ID 530513_20600AMY00224000_A_02_02

Leuシリーズ

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.

Free Database
Powered by Pure Global AI
PMDA Official Data
Bilingual (EN/JP)
IVD
IVD
530513_20600AMY00224000_A_02_02
IVD
IVD
Leu series
Leuシリーズ
PMDA ID: 530513_20600AMY00224000_A_02_02
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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
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
Product Names / 製品名
Market Name (English)
Leu series
Market Name (日本語)
Leuシリーズ