Vietnam MOH registration 2300551ĐKLH/BYT-HTTB
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
Vietnam·Risk Class TTBYT Loại C·therascreen® IDH1/2 RGQ PCR Kit·Veracyte SAS·Registered Jun 20, 2023Registration details
- Analysis ID
- 2300551ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-201026-0013
- Product Type
- therascreen® IDH1/2 RGQ PCR Kit
- Product Code
- 873011
Company information
- Manufacturer
- Veracyte SAS
- Manufacturer Country
- FRANCE
Technical details
- Intended Use
- 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
- Registration Date
- Jun 20, 2023
About this record
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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