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Qualitative Mutation Detection Assay for MGMT Methylation - Vietnam Registration 2400288ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Qualitative Mutation Detection Assay for MGMT Methylation 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 2400288ĐKLH/BYT-HTTB and manufactured by Entrogen, Inc. The authorized representative in Vietnam is CÔNG TY TNHH CÔNG NGHỆ SINH HỌC MBS.

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Registration Details
Vietnam MOH Registration: 2400288ĐKLH/BYT-HTTB
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Device Details

Qualitative Mutation Detection Assay for MGMT Methylation
VN: Bộ xét nghiệm định tính đột biến methyl hóa MGMT
Risk Class TTBYT Loại C

Registration Details

2400288ĐKLH/BYT-HTTB

000.00.04.G18-220920-0009

MGMT Methylation Detection Kit with Bisulfite Conversion Kit

MGMT-RT44

Company Information

UNITED STATES

Entrogen, Inc

Technical Details

The MGMT Methylation Detection Kit with Bisulfite Conversion Kit is a specific PCR (MSP) test designed to detect O (6) methylguanine-DNA methyltransferase (MGMT) in the DNA of diverse glioblastoma (GBM) tumors. The methylation of the MGMT promoter has been shown to confer increased sensitivity to alkylating agents such as temozolomide and has prognostic significance [1,2]

Dates and Status

Feb 23, 2024