Taiwan FDA registration 525f4edd10001cf10ee71281f338b9b8

"Kaijie" Epidermal Growth Factor Receptor Amplification Response Mutation Test Set Enhanced

TW: "凱杰" 表皮生長因子接受器擴增反應突變檢驗試劑組加強型

Taiwan·Risk Class 3·QIAGEN GMBH·Registered Aug 08, 2023 – Aug 08, 2028Active

Registration details

Analysis ID: 525f4edd10001cf10ee71281f338b9b8
Customs Code: DHA05603620901

Company information

Manufacturer: QIAGEN GMBH
Manufacturer Country: Germany
Authorized Representative: QIAGEN TAIWAN COMPANY LIMITED

Product details

Intended Use: 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.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Aug 08, 2023
Expiry Date: Aug 08, 2028

About this record

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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