Vietnam MOH registration 2403161ĐKLH/BYT-HTTB

Comprehensive Quantitative Analysis of Mycophenolic Acid Test Solution

VN: Thuốc thử xét nghiệm định lượng acid mycophenolic toàn phần

Vietnam·Risk Class TTBYT Loại C·MPA·Roche Diagnostics GmbH·Registered Nov 02, 2024

Registration details

Analysis ID: 2403161ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240701-0008
Product Type: MPA
Product Code: 04357213190

Company information

Manufacturer: Roche Diagnostics GmbH
Manufacturer Country: GERMANY
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: In vitro testing used to quantify the total concentration of mycophenolic acid in plasma or serum, to support the monitoring of mycophenolic acid treatment in kidney and heart transplant patients on the COBAS and COBAS INTEGRA systems.

Dates and status

Registration Date: Nov 02, 2024

About this record

Access comprehensive regulatory information for Comprehensive Quantitative Analysis of Mycophenolic Acid Test Solution 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 2403161ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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