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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.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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819750b723206a284a5a3e9f07a1d99a
Registration Details
Taiwan FDA Registration: 819750b723206a284a5a3e9f07a1d99a
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Device Details

Edira KRAS Gene Mutation Test Kit
TW: ๅŸƒ่ฟชๆ‹‰KRASๅŸบๅ› ็ช่ฎŠๆชขๆธฌๅฅ—็ต„
Risk Class 3

Registration Details

819750b723206a284a5a3e9f07a1d99a

DHA05603490409

Company Information

Belgium

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