Vietnam MOH registration 2301689ĐKLH/BYT-HTTB
The 29 Somatic Mutations Detection Kit in the EGFR Gene
VN: Bộ xét nghiệm phát hiện 29 đột biến soma trong gen EGFR
Vietnam·Risk Class TTBYT Loại C·therascreen® EGFR RGQ PCR Kit·QIAGEN GmbH·Registered Dec 22, 2023Registration details
- Analysis ID
- 2301689ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-200826-0027
- Product Type
- therascreen® EGFR RGQ PCR Kit
- Product Code
- 874111
Company information
- Manufacturer
- QIAGEN GmbH
- Manufacturer Country
- GERMANY
Technical details
- Intended Use
- therascreen EGFR RGQ PCR Kit is an in vitro diagnostic test to detect 29 somatic mutations in the EGFR gene. The test provides a qualitative assessment of the mutation status in tumor tissue samples from patients with non-small cell lung cancer (NSCLC). The results aim to support the clinical decision-making process in identifying NSCLC patients who may benefit from EGFR tyrosine kinase inhibitor therapy. therascreen EGFR RGQ PCR Kit will test DNA samples extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue from NSCLC patients and run on the Rotor-Gene Q MDx 5plex HRM device. The test must be performed by trained laboratory personnel. therascreen EGFR RGQ PCR Kit is designed for in vitro diagnostic use.
Dates and status
- Registration Date
- Dec 22, 2023
About this record
Access comprehensive regulatory information for The 29 Somatic Mutations Detection Kit in the EGFR Gene 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 2301689ĐKLH/BYT-HTTB and manufactured by QIAGEN GmbH.
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