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“QIAGEN” therascreen EGFR RGQ PCR kit - Taiwan Registration fd3d10c7840d4f1d0530ee88373e2016

Access comprehensive regulatory information for “QIAGEN” therascreen EGFR RGQ PCR kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number fd3d10c7840d4f1d0530ee88373e2016 and manufactured by QIAGEN GMBH. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

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fd3d10c7840d4f1d0530ee88373e2016
Registration Details
Taiwan FDA Registration: fd3d10c7840d4f1d0530ee88373e2016
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Device Details

“QIAGEN” therascreen EGFR RGQ PCR kit
TW: “凱杰” 表皮生長因子接受器擴增反應突變檢驗試劑組
Risk Class 3
MD

Registration Details

fd3d10c7840d4f1d0530ee88373e2016

Ministry of Health Medical Device Import No. 030485

DHA05603048508

Company Information

Germany

Product Details

This product can detect 29 somatic mutations in EGFR gene in vitro, and can qualitatively evaluate the mutation status of tumor samples from patients with non-small cell lung cancer (NSCLC). The results of the assessment can be used to help clinicians identify patients with NSCLC who may benefit from EGFR tyrosine kinase inhibitor therapy.

B Hematology and pathology devices

B4020 Analyze specific reagents

Imported from abroad

Dates and Status

Jan 19, 2018

Jan 19, 2028