Vietnam MOH registration 2403539ĐKLH/BYT-HTTB

Drug test, reference standard for quantitative antibody IgG against HEV

VN: Thuốc thử, chất hiệu chuẩn xét nghiệm định lượng kháng thể IgG kháng HEV

Vietnam·Risk Class TTBYT Loại C·Elecsys Anti-HEV IgG·Roche Diagnostics GmbH·Registered Nov 14, 2024

Registration details

Analysis ID: 2403539ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-231218-0028
Product Type: Elecsys Anti-HEV IgG
Product Code: 09044647190

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 quantitatively determine the presence of IgG antibodies against the hepatitis E virus (HEV) in human serum and plasma. The Elecsys Anti-HEV IgG test is used to support the detection of recent or past HEV infection. The electrochemiluminescence immunoassay (ECLIA) is used in the cobas e immunoassay system.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for Drug test, reference standard for quantitative antibody IgG against HEV 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 2403539ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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