Multi-item automatic blood cell analyzer XT-1800i - PMDA ID 480585_28B1X10014000055_A_04_01
Access comprehensive regulatory information for Multi-item automatic blood cell analyzer XT-1800i (多項目自動血球分析装置 ＸＴ−１８００i) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 480585_28B1X10014000055_A_04_01 and manufactured by Manufacture and sales/Sysmex Corporation. The device information was last updated on September 04, 2020.
This page provides complete registration details including device class (A1700), classification (blood cell counter / 血球計数装置), 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.
It is a medical device for in vitro testing and measures the following items. WBC (white blood cell count), RBC (red blood cell count), HGB (hemoglobin concentration), HCT (hematocrit), MCV (mean corpuscular volume), MCH (mean corpuscular hemoglobin content), MCHC (mean corpuscular hemoglobin concentration), PLT (platelet count), NEUT% (neutrophil ratio), LYMPH% (lymphocyte ratio), MONO% (monocyte ratio), EO% (eosinophil ratio) , BASO% (basophil ratio), NEUT# (neutrophil count), LYMPH# (lymphocyte count), MONO# (monocyte count), EO# (eosinophil count), BASO# (halophil count). Please be sure to refer to the instruction manual. Code No.461-9708-5
検体検査用医療機器であり、次の項目の測定を行います。WBC（白血球数）、RBC（赤血球数）、HGB（ﾍﾓｸﾞﾛﾋﾞﾝ濃度）、HCT（ﾍﾏﾄｸﾘｯﾄ値）、MCV（平均赤血球容積）、MCH（平均赤血球ﾍﾓｸﾞﾛﾋﾞﾝ量）、MCHC（平均赤血球ﾍﾓｸﾞﾛﾋﾞﾝ濃度）、PLT（血小板数）、NEUT%（好中球比率）、LYMPH%（ﾘﾝﾊﾟ球比率）、MONO%（単球比率）、EO%（好酸球比率）、BASO%（好塩基球比率）、NEUT#（好中球数）、LYMPH#（ﾘﾝﾊﾟ球数）、MONO#（単球数）、EO#（好酸球数）、BASO#（好塩球数）を測定します。取扱説明書を必ずご参照ください。Code No.461-9708-5