Edira KRAS Gene Mutation Test Kit - Taiwan Registration 819750b723206a284a5a3e9f07a1d99a
Access comprehensive regulatory information for Edira KRAS Gene Mutation Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 819750b723206a284a5a3e9f07a1d99a and manufactured by BIOCARTIS NV. The authorized representative in Taiwan is REFERENCE TECHNOLOGY LIMITED COMPANY.
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Device Details
Product Details
This product is an in vitro diagnostic detection reagent for the qualitative detection of mutations in codons 12, 13, 59, 61, 117 or 146 of the KRAS oncogen. This product is suitable for tissue section samples of human colon cancer (CRC) with formalin-fixed, paraffin-embedded (FFPE).
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
Input;; QMS/QSD
Dates and Status
Sep 08, 2021
Sep 08, 2026

