"Kaijie" Epidermal Growth Factor Receptor Amplification Response Mutation Test Set Enhanced - Taiwan Registration 525f4edd10001cf10ee71281f338b9b8
Access comprehensive regulatory information for "Kaijie" Epidermal Growth Factor Receptor Amplification Response Mutation Test Set Enhanced in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 525f4edd10001cf10ee71281f338b9b8 and manufactured by QIAGEN GMBH. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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Device Details
Product Details
This product is an in vitro diagnostic real-time PCR test for the qualitative detection and identification of epidermal growth factor receptor (EPG) in formalin-fixed paraffin-embedded (FFPE) tumor tissue and plasma from patients with non-small cell lung cancer (NSCLC). Factor Receptor (EGFR) gene with mutations in exons 18, 19, 20, and 21. This product is also suitable for semi-quantitative measurement of mutations in exon 18, 20 and 21 of the EGFR gene in human plasma, which is used to assist in the management of NSCLC cancer patients.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Aug 08, 2023
Aug 08, 2028