Vietnam MOH registration 2400188ĐKLH/BYT-HTTB
The test kit detects mutations at exons 19, 20, and 21 of the EGFR gene
VN: Bộ xét nghiệm phát hiện các đột biến ở exon 19, exon 20 và 21 trên gen EGFR
Vietnam·Risk Class TTBYT Loại C·therascreen® EGFR Plasma RGQ PCR Kit·QIAGEN GmbH·Registered Feb 04, 2024Registration details
- Analysis ID
- 2400188ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-200826-0021
- Product Type
- therascreen® EGFR Plasma RGQ PCR Kit
- Product Code
- 870311
Company information
- Manufacturer
- QIAGEN GmbH
- Manufacturer Country
- GERMANY
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG
Technical details
- Intended Use
- therascreen EGFR Plasma RGQ PCR kit is an in vitro diagnostic test kit to detect the loss of exon 19, and the substitution of exons 20 and 21 (corresponding to T790M and L858R) in the gene of the epidermal growth factor receptor (EGFR) and will provide qualitative assessment of the mutation status. The results aim to support the clinical decision-making process in determining which patients with NSCLC may benefit from treatment with IRESSA (gefitinib), when tissue biopsy samples cannot be obtained. therascreen EGFR Plasma RGQ PCR Kit is used by trained professionals in the laboratory environment with DNA samples extracted from the plasma obtained from the blood of patients with non-small cell lung cancer (NSCLC). therascreen EGFR Plasma RGQ PCR Kit is used in in vitro diagnosis
Dates and status
- Registration Date
- Feb 04, 2024
About this record
Access comprehensive regulatory information for The test kit detects mutations at exons 19, 20, and 21 of 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 2400188ĐKLH/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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