Taiwan FDA registration e9e3b1d3a7437e0e181bf9e2500dd9c2
Formosa KRAS Mutation Detection Kit
TW: 台塑生醫KRAS基因突變檢測套組
Taiwan·Risk Class 3·MD·Formosa Biomedical Technology Co., Ltd. Yilan Factory·Registered Feb 21, 2018 – Feb 21, 2028ActiveRegistration details
- Analysis ID
- e9e3b1d3a7437e0e181bf9e2500dd9c2
- License Form
- Ministry of Health Medical Device Manufacturing No. 005818
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION
Product details
- Intended Use
- This product is used to detect patients with metastatic colorectal cancer whose tumors carry mutations in the positions of KRAS gene Codon12 and 13, and to screen out patients who can be treated with EGFR monoclonal antibodies. This product is only used for clinical auxiliary diagnosis, and the physician must judge the actual situation of the case when applying it clinically, and cannot use the test results of this product as the only basis. This product is suitable for the specimen of formarin fixed paraffin-embedded tissue.
- 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
- Feb 21, 2018
- Expiry Date
- Feb 21, 2028
About this record
Access comprehensive regulatory information for Formosa KRAS 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 e9e3b1d3a7437e0e181bf9e2500dd9c2 and manufactured by Formosa Biomedical Technology Co., Ltd. Yilan Factory. The authorized representative in Taiwan is FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION.
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