Vietnam MOH registration 2400518ĐKLH/BYT-HTTB
Qualitative genotyping test for NRAS mutation
VN: Bộ xét nghiệm định tính đột biến gen NRAS
Vietnam·Risk Class TTBYT Loại C·PNAClamp NRAS Mutation Detection Kit·PANAGENE Inc.·Registered Apr 10, 2024Registration details
- Analysis ID
- 2400518ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220506-0014
- Product Type
- PNAClamp NRAS Mutation Detection Kit
- Product Code
- PNAC-1101
Company information
- Manufacturer
- PANAGENE Inc.
- Manufacturer Country
- REPUBLIC OF
- Product Owner
- PANAGENE Inc.
- Authorized Representative
- CÔNG TY CỔ PHẦN VẬT TƯ KHOA HỌC BIOMEDIC
Technical details
- Intended Use
- The PNAClamp NRAS Mutation Detection Kit is an in vitro diagnostic test kit for the detection of 43 clinically significant mutations in the NRAS cancer gene. The kit is used by trained laboratory specialists in the laboratory environment, using (for example) DNA extracted from formalin-fixed, paraffin-embedded lung and colorectal biopsy samples and surgical tissue samples. It is an in vitro diagnostic test kit.
Dates and status
- Registration Date
- Apr 10, 2024
About this record
Access comprehensive regulatory information for Qualitative genotyping test for NRAS mutation 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 2400518ĐKLH/BYT-HTTB and manufactured by PANAGENE Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN VẬT TƯ KHOA HỌC BIOMEDIC.
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