Edira EGFR Gene Mutation Test Kit - Taiwan Registration b480bb290387f2bbccb3440ca21a537e
Access comprehensive regulatory information for Edira EGFR 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 b480bb290387f2bbccb3440ca21a537e 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, exon 19 deletions and exon 20 insertion in epidermal growth factor receptor (EGFR) genes in exon 18 (G719A/C/S), EXON 21 (L858R, L861Q), exon 20 (T790M, S768I). This product is suitable for formalin-fixed, paraffin-embedded (FFPE) tissue section samples of human non-small cell lung cancer (NSCLC). This product covers the entire process from FFPE sampling to results, including sample preparation, nucleic acid release, Real-Time PCR amplification and detection, and data analysis.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
Input;; QMS/QSD
Dates and Status
Oct 22, 2020
Oct 22, 2025