Vietnam MOH registration 2400887ĐKLH/BYT-HTTB

IVD Department quantitative Vancomycin testing

VN: Bộ IVD xét nghiệm định lượng Vancomycin

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Jun 24, 2024

Registration details

Analysis ID: 2400887ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210325-0030
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: VĂN PHÒNG ĐẠI DIỆN BECKMAN COULTER HONG KONG LIMITED TẠI TPHCM

Technical details

Intended Use: 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

Registration Date: Jun 24, 2024

About this record

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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