Vietnam MOH registration 2403395ĐKLH/BYT-HTTB

Drug test, reference standard for qualitative antibody IgM against cytomegalovirus (CMV)

VN: Thuốc thử, chất hiệu chuẩn xét nghiệm định tính kháng thể IgM kháng cytomegalovirus (CMV)

Vietnam·Risk Class TTBYT Loại D·Elecsys CMV IgM·Roche Diagnostics GmbH·Registered Nov 06, 2024

Registration details

Analysis ID: 2403395ĐKLH/BYT-HTTB
Submission ID: 17001587/ĐKLH-BYT-TB-CT
Product Type: Elecsys CMV IgM
Product Code: 07027133190

Company information

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

Technical details

Intended Use: In vitro immunoassay for the qualitative determination of IgM antibodies against cytomegalovirus in human serum and plasma. The results obtained with the in vitro immunoassay used as a diagnostic tool for the detection of new CMV infections. The electrochemiluminescence immunoassay “ECLIA” (electrochemiluminescence immunoassay “ECLIA”) is used in base immunodiagnostic analyzers.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Drug test, reference standard for qualitative antibody IgM against cytomegalovirus (CMV) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403395ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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