Taiwan FDA registration b11689042af3404c437517758863dd38
Formosa EGFR Mutation Detection Kit
TW: 台塑生醫EGFR基因突變檢測套組
Taiwan·Risk Class 3·MD·Formosa Biomedical Technology Co., Ltd. Yilan Factory·Registered Nov 03, 2015 – Nov 03, 2025ExpiredRegistration details
- Analysis ID
- b11689042af3404c437517758863dd38
- License Form
- Ministry of Health Medical Device Manufacturing No. 004963
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION
Product details
- Intended Use
- This product is used to identify patients with end-stage non-small cell lung cancer whose tumors carry EGFR gene E19del, L858R, T790M, G719X, S768I, L861Q and E20ins mutations, and screen out patients who can be treated with small molecule tyrosine kinase inhibitor. This product is only used for clinical auxiliary diagnosis, and the physician must judge the actual situation of the case during clinical application, and cannot use the test results of this product as the only basis. This product is only suitable for formalin-fixed, paraffin-embedded tissue and pulmonary costal fluid (using both cellular DNA and cell-free DNA).
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B4020 Analyze specific reagents
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Nov 03, 2015
- Expiry Date
- Nov 03, 2025
About this record
Access comprehensive regulatory information for Formosa EGFR Mutation Detection Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number b11689042af3404c437517758863dd38 and manufactured by Formosa Biomedical Technology Co., Ltd. Yilan Factory. The authorized representative in Taiwan is FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION.
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