Vietnam MOH registration 2400288ĐKLH/BYT-HTTB
Qualitative Mutation Detection Assay for MGMT Methylation
VN: Bộ xét nghiệm định tính đột biến methyl hóa MGMT
Vietnam·Risk Class TTBYT Loại C·MGMT Methylation Detection Kit with Bisulfite Conversion Kit·Entrogen, Inc·Registered Feb 23, 2024Registration details
- Analysis ID
- 2400288ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220920-0009
- Product Type
- MGMT Methylation Detection Kit with Bisulfite Conversion Kit
- Product Code
- MGMT-RT44
Company information
- Manufacturer
- Entrogen, Inc
- Manufacturer Country
- UNITED STATES
- Product Owner
- Entrogen, Inc
- Authorized Representative
- CÔNG TY TNHH CÔNG NGHỆ SINH HỌC MBS
Technical details
- Intended Use
- 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
- Registration Date
- Feb 23, 2024
About this record
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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