Vietnam MOH registration 2401203ĐKLH/BYT-HTTB

Quantitative DNA Test for Epstein-Barr Virus (EBV)

VN: Bộ xét nghiệm định lượng DNA của Epstein-Barr virus (EBV)

Vietnam·Risk Class TTBYT Loại C·artus® EBV QS-RGQ Kit·QIAGEN GmbH·Registered Aug 14, 2024

Registration details

Analysis ID: 2401203ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-200924-0026
Product Type: artus® EBV QS-RGQ Kit
Product Code: 4501363

Company information

Manufacturer: QIAGEN GmbH
Manufacturer Country: GERMANY
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG

Technical details

Intended Use: The Artus EBV QS-RGQ Kit is an in vitro nucleic acid amplification test for quantifying the DNA of Epstein-Barr virus (EBV). This diagnostic test uses the polymerase chain reaction (PCR) and is designed to be used with the QIAsymphony SP/AS and Rotor Gene Q. The Artus EBV QS-RGQ Kit is designed to be used in conjunction with clinical manifestations and other biomarkers to predict the disease.

Dates and status

Registration Date: Aug 14, 2024

About this record

Access comprehensive regulatory information for Quantitative DNA Test for Epstein-Barr Virus (EBV) 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 2401203ĐKLH/BYT-HTTB and manufactured by QIAGEN GmbH. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.