Vietnam MOH registration 2301630ĐKLH/BYT-HTTB

Quantitative Methylation Status Assay for the Exon 1 of the MGMT Gene

VN: Bộ xét nghiệm định lượng tình trạng methyl hóa trong exon 1 của gen MGMT

Vietnam·Risk Class TTBYT Loại C·Therascreen® MGMT Pyro® Kit·QIAGEN GmbH·Registered Nov 22, 2023

Registration details

Analysis ID: 2301630ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-200625-0010
Product Type: Therascreen® MGMT Pyro® Kit
Product Code: 971061

Company information

Manufacturer: QIAGEN GmbH
Manufacturer Country: GERMANY

Technical details

Intended Use: The therascreen MGMT Pyro Kit is an in vitro diagnostic test used to detect the sequence of nucleic acid based on the Pyrosequencing® technology to quantify the methylation status in the exon 1 of the MGMT gene in the DNA from human tissue samples. The therascreen MGMT Pyro Kit is used as an additional diagnostic test alongside other predictive factors and provides the clinical oncologist with information to select patients who are likely to benefit from chemotherapy. It is intended for in vitro diagnostic use. It is intended for use on the PyroMark® Q24 system. The PyroMark Q24 system consists of the following products: • The PyroMark Q24 and PyroMark Q24 MDx instruments. • The PyroMark Q24 Vacuum Workstation and the PyroMark Q24 MDx Vacuum Workstation. • The PyroMark Q24 Software (version 2.0) and the PyroMark Q24 MDx Software (version 2.0). The products are intended to be used by qualified individuals, such as laboratory technicians and medical laboratory personnel, who are trained in in vitro diagnostic testing, molecular biology, and the PyroMark Q24 system.

Dates and status

Registration Date: Nov 22, 2023

About this record

Access comprehensive regulatory information for Quantitative Methylation Status Assay for the Exon 1 of the MGMT Gene 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 2301630ĐKLH/BYT-HTTB and manufactured by QIAGEN GmbH.

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