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Qualitative Assay Kit for 7 IDH1 Genomic Mutations and 5 IDH2 Genomic Mutations - Vietnam Registration 2300551ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Qualitative Assay Kit for 7 IDH1 Genomic Mutations and 5 IDH2 Genomic Mutations 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 2300551ĐKLH/BYT-HTTB and manufactured by Veracyte SAS.

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2300551ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2300551ĐKLH/BYT-HTTB
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Device Details

Qualitative Assay Kit for 7 IDH1 Genomic Mutations and 5 IDH2 Genomic Mutations
VN: Bộ xét nghiệm định tính 7 đột biến gen IDH1 và 5 đột biến gen IDH2
Risk Class TTBYT Loại C

Registration Details

2300551ĐKLH/BYT-HTTB

000.00.04.G18-201026-0013

therascreen® IDH1/2 RGQ PCR Kit

873011

Company Information

FRANCE

Technical Details

Therascreen IDH1/2 RGQ PCR Kit is an in vitro diagnostic test based on PCR technology, designed to qualitatively detect 7 IDH1 gene mutations and 5 IDH2 gene mutations, and to directly determine the 3 primary mutations in the DNA extracted from formalin-fixed human brain tissue (FFPE). The Therascreen IDH1/2 RGQ PCR Kit is used to assist in the classification of glioma

Dates and Status

Jun 20, 2023