IVD Department quantitative Vancomycin testing - Vietnam Registration 2400887ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative Vancomycin testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400887ĐKLH/BYT-HTTB. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BECKMAN COULTER HONG KONG LIMITED TẠI TPHCM.
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Device Details
Registration Details
2400887ĐKLH/BYT-HTTB
000.00.04.G18-210325-0030
Theo theo phụ lục
Theo phụ lục
Technical Details
Emit 2000 Vancomycin Calibrators: Used with the Vancomycin Emit 2000 Assay to determine the concentration of vancomycin in human plasma or serum, serving as a reference standard. Emit 2000 Vancomycin Assay: An enzyme-linked immunosorbent assay (ELISA) used to quantitatively analyze vancomycin in human plasma or serum. The results obtained from this device are utilized in the diagnosis and treatment of vancomycin toxicity and in monitoring vancomycin concentrations to ensure appropriate therapy.
Dates and Status
Jun 24, 2024