Vietnam MOH registration 2403555ĐKLH/BYT-HTTB

Quantitative Immunoassay Control Material 12 Parameters

VN: Vật liệu kiểm soát xét nghiệm định lượng 12 thông số miễn dịch

Vietnam·Risk Class TBYT Loại C·PreciControl Tumor Marker·Roche Diagnostics GmbH·Registered Nov 14, 2024

Registration details

Analysis ID: 2403555ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240826-0002
Product Type: PreciControl Tumor Marker
Product Code: 11776452122

Company information

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

Technical details

Intended Use: PreciControl Tumor Marker is used to assess the quality of the Elecsys immunoassay tests performed on the cobas e immunoassay analyzer.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Quantitative Immunoassay Control Material 12 Parameters in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403555ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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