Hematology analyzer and automated blood sedimentation rate measurement - Vietnam Registration 240000067/PCBB-BN

For in vitro diagnostic use only. The MEK-1305 hematology analyzer and the automated measurement of the erythrocyte sedimentation rate (ESR) is designed for in vitro diagnostic use to automatically classify and quantify the following parameters (full blood count, CBC and ESR) in EDTA-anticoagulated whole blood from patients as a diagnostic aid in clinical laboratories:White blood cell count (WBC), Lymphocyte count and percentage (LY and LY%), Monocyte count and percentage (MO and MO%), Eosinophil count and percentage (GR and GR%), Red blood cell count (RBC), Hemoglobin concentration (HGB), Hematocrit percentage (HCT), Mean corpuscular volume (MCV), Mean hemoglobin concentration (MCH), Mean hemoglobin concentration per red blood cell (MCHC), Platelet count (PLT), Coefficient of variation of the red blood cell size distribution (RDW-CV), Standard deviation of the red blood cell size distribution (RDW-SD), Plateletcrit (PCT), Mean platelet volume (MPV), Platelet size distribution (PDW), Proportion of large platelets (P-LCR), and Erythrocyte sedimentation rate (ESR). The measurement of CBC and ESR can support the diagnosis of anemia, inflammation, and infection. The target population for testing is the general population being evaluated for various conditions. The MEK-1305 hematology analyzer and the automated measurement of the erythrocyte sedimentation rate (ESR) is intended for use by laboratory personnel only.