Automated Hematology Analyzer
Vietnam·Risk Class TTBYT Loại B·Yumizen H550·Horiba ABX SAS·Registered Apr 18, 2023- Analysis ID
- 230000018/PCBB-BD
- Submission ID
- 000.00.17.H09-230414-0008
- Product Type
- Yumizen H550
- Manufacturer
- Horiba ABX SAS
- Intended Use
- Yumizen H550 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 H550 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 patient population found in clinical laboratories. It is quantitative to measure the parameters and qualitative to detect the warnings. The purpose of Yumizen H550 is to determine the samples of human blood as: -venous blood -capillary blood obtained in blood anticoagulant tubes with K2-EDTA and K3-EDTA. The purpose of Yumizen H550 is to determine the samples of human blood as: - pediatrics (newborns, children, infants, adolescents) - adult population
- Registration Date
- Apr 18, 2023
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