Vietnam MOH registration 2401196ĐKLH/BYT-HTTB

Qualitative Assay Kit for 7 Somatic Mutations in Codons 12 and 13 of the KRAS Gene

VN: Bộ xét nghiệm định tính 7 đột biến soma trong codon 12 và 13 trên gen KRAS

Vietnam·Risk Class TTBYT Loại C·therascreen® KRAS RGQ PCR Kit·QIAGEN GmbH·Registered Aug 14, 2024

Registration details

Analysis ID: 2401196ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-200826-0020
Product Type: therascreen® KRAS RGQ PCR Kit
Product Code: 874011

Company information

Manufacturer: QIAGEN GmbH
Manufacturer Country: GERMANY
Authorized Representative: CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG

Technical details

Intended Use: therascreen® KRAS RGQ PCR Kit is a qualitative real-time PCR test for the detection of 7 somatic mutations in codon 12 and 13 of the KRAS cancer-causing gene in human DNA, using the Rotor-Gene Q MDx 5plex HRM device. This chemical kit is used in conjunction with DNA extracted from formalin-fixed paraffin-embedded (FFPE) samples of colorectal cancer (CRC) or non-small cell lung cancer (NSCLC) obtained by resection, core needle biopsy (CNB), or fine needle aspiration (FNA). Somatic mutations in the KRAS gene are a predictive biomarker of resistance to epidermal growth factor (EGFR) targeted therapies such as panitumumab and cetuximab in the treatment of CRC. The therascreen KRAS RGQ PCR Kit also aims to support the identification of NSCLC patients for treatment with sotorasib (LUMYKRAS®) based on the detection of the KRAS G12C mutation. Somatic mutations in the KRAS gene may also be considered a predictive biomarker for decision-making in the context of other NSCLC therapies. The mutational status of the patient will be considered alongside other clinical factors by the treating physician in making treatment decisions. It should not be the sole basis for treatment decisions in cancer patients. The therascreen KRAS RGQ PCR Kit is not intended for the diagnosis of CRC, NSCLC, or any other condition. therascreen KRAS RGQ PCR Kit is an in vitro diagnostic medical device. therascreen KRAS RGQ PCR Kit is intended for use by trained professionals in a professional laboratory setting.

Dates and status

Registration Date: Aug 14, 2024

About this record

Access comprehensive regulatory information for Qualitative Assay Kit for 7 Somatic Mutations in Codons 12 and 13 of the KRAS 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 2401196ĐKLH/BYT-HTTB and manufactured by QIAGEN GmbH. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

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