Vietnam MOH registration 2403585ĐKLH/BYT-HTTB
Qualitative Mutation Detection Kit for KRAS and NRAS Exons 2, 3, 4
VN: Bộ xét nghiệm định tính các đột biến KRAS và NRAS exon 2, 3, 4
Vietnam·Risk Class TTBYT Loại C·CRCdx RAS Mutation Detection Kit·Entrogen, Inc·Registered Nov 14, 2024Registration details
- Analysis ID
- 2403585ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-240806-0009
- Product Type
- CRCdx RAS Mutation Detection Kit
- Product Code
- CRCDX-RAS
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
- CRCdx RAS Mutation Detection Kit is an in vitro real-time PCR qualitative diagnostic test designed to detect 35 mutations of the KRAS and NRAS exon 2, 3, 4 in the DNA of the gene extracted from the formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample of colorectal cancer (CRC). The test aims to provide a companion diagnostic (CDx) to assist in determining which patients with CRC may benefit from treatment with Vectibix® (panitumumab) based on the absence of a mutation as per the approved treatment product label. The CRCdx RAS test is performed on the QuantStudio™ Dx real-time PCR (QSDx) device to analyze the test and collect data. The data are analyzed using EntroGen’s PCR Analysis Software (EPAS™) to interpret the results.
Dates and status
- Registration Date
- Nov 14, 2024
About this record
Access comprehensive regulatory information for Qualitative Mutation Detection Kit for KRAS and NRAS Exons 2, 3, 4 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 2403585ĐKLH/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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