Automated Hematology Analyzer
Vietnam·Risk Class TTBYT Loại B·Yumizen H500 CT·Horiba ABX SAS·Registered Apr 18, 2023- Analysis ID
- 230000017/PCBB-BD
- Submission ID
- 000.00.17.H09-230414-0007
- Product Type
- Yumizen H500 CT
- Manufacturer
- Horiba ABX SAS
- Intended Use
- Yumizen H500 CT classifies and lists the following parameters in the whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, MIC, MAC, PLT, MPV, PCT, PDW, P-LCC, P-LCR, LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BAS#, BAS%, ALY#, ALY%, LIC#, LIC%, IML#, IML%, IMM#, IMM%, IMG#, IMG%. Yumizen H500 CT provides information for in vitro diagnostic use in clinical laboratories. It is used to screen the physiological state (detection of quantitative or qualitative abnormalities in hematology) or the pathological state of the population of patients found in clinical laboratories. It is quantitative to measure the parameters and qualitative to detect the warnings. The purpose of Yumizen H500 CT is to determine blood samples from humans as: -venous blood -capillary blood obtained in blood anticoagulated with K2-EDTA and K3-EDTA. The purpose of Yumizen H500 CT is to determine blood samples from humans as: - pediatrics (newborns, children, infants, adolescents) - adult population
- Registration Date
- Apr 18, 2023
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