XR series Hematology Automation Testing System - Vietnam Registration 240000066/PCBB-BYT
Access comprehensive regulatory information for XR series Hematology Automation Testing System in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000066/PCBB-BYT and manufactured by SYSMEX CORPORATION. The authorized representative in Vietnam is CÔNG TY TNHH SYSMEX VIỆT NAM.
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Device Details
Registration Details
240000066/PCBB-BYT
000.00.04.G18-220420-0026
Theo theo phụ lục
Theo phụ lục
Technical Details
The XR-series Hematology Analyzer is a multi-parameter automated blood analysis instrument designed for the classification and quantification of the following parameters in the whole blood and body fluids, to assist in the diagnosis of patient populations in clinical laboratories. It is used for in vitro diagnosis in clinical laboratories. •Whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MicroR, MacroR, PDW, MPV, P-LCR, PCT, NRBC%, NRBC#, NEUT%, NEUT#, LYMPH%, LYMPH#, MONO%, MONO#, EO%, EO#, BASO%, BASO#, IG%, IG#, AS-LYMP%, AS-LYMP#, RE-LYMP%, RE-LYMP#, NEUT-RI, NEUT-GI, RET%, RET#, IRF, LFR, MFR, HFR, RET-He, RBC-He, Delta-He, HYPO-He, HYPER-He, IPF, IPF#, HPC%, HPC#. •Body fluids (cerebrospinal fluid, peritoneal fluid (abdominal membrane, lung membrane), joint fluid and peritoneal dialysis fluid (CAPD)): WBC-BF, RBC-BF, TC-BF#, MN%, MN#, PMN%, PMN#. The XR-series Hematology Analyzer is used by healthcare professionals and properly trained staff.
Dates and Status
Jul 16, 2024