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Leu Series Simul Test - PMDA ID 530513_16200EZY00552000_A_01_02

Leu シリーズサイマルテスト

Access comprehensive regulatory information for Leu Series Simul Test (Leu シリーズサイマルテスト) in the Japan medical device market through Pure Global AI's free bilingual database. This IVD medical device is registered under PMDA ID 530513_16200EZY00552000_A_01_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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PMDA Official Data
Bilingual (EN/JP)
IVD
IVD
530513_16200EZY00552000_A_01_02
IVD
IVD
Leu Series Simul Test
Leu シリーズサイマルテスト
PMDA ID: 530513_16200EZY00552000_A_01_02
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Intended Use / 使用目的
English

Analysis of lymphocyte cell surface antigens in whole blood or mononuclear cells and determination of T cell count and T cell subset

日本語 (Japanese)

全血又は単核細胞中のリンパ球細胞表面抗原の分析並びにT細胞数及びT細胞サブセットの測定

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_16200EZY00552000_A_01_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 Simul Test
Market Name (日本語)
Leu シリーズサイマルテスト