Vietnam MOH registration 240000066/PCBB-BYT

XR series Hematology Automation Testing System

VN: Hệ thống xét nghiệm huyết học tự động XR series

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·SYSMEX CORPORATION·Registered Jul 16, 2024

Registration details

Analysis ID: 240000066/PCBB-BYT
Submission ID: 000.00.04.G18-220420-0026
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: SYSMEX CORPORATION
Manufacturer Country: Theo theo phụ lục
Product Owner: SYSMEX CORPORATION
Authorized Representative: CÔNG TY TNHH SYSMEX VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Jul 16, 2024

About this record

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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