Automated Hematology Analyzer
Vietnam·Risk Class TBYT Loại B·MEK-9200·Nihon Kohden·Registered Sep 30, 2024- Analysis ID
- 240000066/PCBB-BN
- Submission ID
- 000.00.16.H05-240911-0003
- Product Type
- MEK-9200
- Manufacturer
- Nihon Kohden
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Nihon Kohden
- Authorized Representative
- CHI NHÁNH CÔNG TY CỔ PHẦN SẢN XUẤT VÀ DỊCH VỤ TRÀNG AN TẠI BẮC NINH
- Intended Use
- It is intended for in vitro diagnostic use only. The MEK-9200 Hematology Analyzer is designed for in vitro diagnostic use to automatically classify and quantify the following parameters (full blood count, CBC, and the 5 differential components of neutrophils and erythrocytes) in EDTA-anticoagulated whole blood: White blood cells (WBC), number and percentage of neutrophils (NE and NE%), number and percentage of lymphocytes (LY and LY%), number and percentage of monocytes (MO and MO%), number and percentage of eosinophils (EO and EO%), number and percentage of basophils (BA and BA%), Red blood cells (RBC), Hemoglobin concentration (HGB), Hematocrit percentage (HCT), Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width based on coefficient of variation (RDW-CV), Red cell distribution width based on standard deviation (RDW-SD), Platelets (PLT), Platelet distribution ratio (PCT), Mean platelet volume (MPV), Platelet width (PDW), Ratio of large platelets (P-LCR), Number of large platelets (P-LCC), Percentage of reticulocytes (RET), Number of reticulocytes (RET), Ratio of immature reticulocytes (IRF), Low fluorescence ratio (LFR), Mean fluorescence ratio (MFR) and High fluorescence ratio (HFR). The measurement of CBC, WBC and reticulocytes can support the diagnosis of anemia, inflammation and infection. The test population group is a general group of patients being evaluated for various conditions. The MEK-9200 Hematology Analyzer is intended for professional use in the laboratory.
- Registration Date
- Sep 30, 2024
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Access comprehensive regulatory information for Automated Hematology Analyzer in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240000066/PCBB-BN and manufactured by Nihon Kohden. The authorized representative in Vietnam is CHI NHÁNH CÔNG TY CỔ PHẦN SẢN XUẤT VÀ DỊCH VỤ TRÀNG AN TẠI BẮC NINH.
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