Vietnam MOH registration 2403384ĐKLH/BYT-HTTB

HEV IgM Antibody Qualitative Test Control Reagent

VN: Thuốc thử, chất hiệu chuẩn xét nghiệm định tính kháng thể IgM kháng HEV

Vietnam·Risk Class TTBYT Loại C·Elecsys Anti-HEV IgM·Roche Diagnostics GmbH·Registered Nov 06, 2024

Registration details

Analysis ID: 2403384ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231218-0029
Product Type: Elecsys Anti-HEV IgM
Product Code: 09056254190

Company information

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

Technical details

Intended Use: The immunoassay test is used to qualitatively determine IgM antibodies against the hepatitis E virus (HEV) in human serum and plasma. The Elecsys Anti-HEV IgM test is used to support the detection of acute or recent HEV infection. The electrochemiluminescence immunoassay (ECLIA) is used for the cobas e immunoassay analyzer.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for HEV IgM Antibody Qualitative Test Control Reagent 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 2403384ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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