Taiwan FDA registration fd3d10c7840d4f1d0530ee88373e2016
“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
Taiwan·Risk Class 3·MD·QIAGEN GMBH·Registered Jan 19, 2018 – Jan 19, 2028ActiveRegistration details
- Analysis ID
- fd3d10c7840d4f1d0530ee88373e2016
- License Form
- Ministry of Health Medical Device Import No. 030485
- Customs Code
- DHA05603048508
Company information
- Manufacturer
- QIAGEN GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- QIAGEN TAIWAN COMPANY LIMITED
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B4020 Analyze specific reagents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jan 19, 2018
- Expiry Date
- Jan 19, 2028
About this record
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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