Automated Hematology Analyzer
Vietnam·Risk Class TBYT Loại B·MEK-1301·Nihon Kohden·Registered Sep 30, 2024- Analysis ID
- 240000064/PCBB-BN
- Submission ID
- 000.00.16.H05-240910-0002
- Product Type
- MEK-1301
- 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
- For in vitro diagnostic use only. The MEK-1301 automated hematology analyzer is designed for in vitro diagnostic use to automatically classify and quantify the following parameters (full blood count, CBC) in the whole blood of EDTA-processed individuals: White blood cells (WBC), number and percentage of lymphocytes (LY and LY%), number and percentage of monocytes (MO and MO%), number and percentage of granulocytes (GR and GR%), number of red blood cells (RBC), concentration of hemoglobin (HGB), percentage (HCT), mean corpuscular volume (MCV), mean hemoglobin concentration (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets (PLT), coefficient of variation of red blood cell distribution width (RDW-CV), standard deviation of red blood cell distribution width (RDW-SD), plateletcrit (PCT), mean platelet volume (MPV), platelet distribution width (PDW), and large platelet ratio (PLCR). The full blood count (CBC) can support the diagnosis of anemia, inflammation, and infection. The test sample is the general population, and the CBC test is used to evaluate various conditions. The MEK-1301 automated hematology analyzer is intended for use in the laboratory setting only.
- 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 240000064/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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