Edira MSI test kit - Taiwan Registration 7a0a72619cac85fbf546f8ad161e1848
Access comprehensive regulatory information for Edira MSI 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 7a0a72619cac85fbf546f8ad161e1848 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 reagent that requires the qualitative detection of 7 monomorphic biomarkers with Biocartis Idylla System to identify colorectal cancer with microsatellite instability (MSI). This product is suitable for human colorectal cancer (CRC) tissue sections with formalin-fixed, paraffin-embedded (FFPE) specimens, from which nucleic acids are released, and then analyzed by PCR amplification and high-resolution melting detection. The entire process of this product from FFPE sample preparation to MSI status reporting is fully automated.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Feb 19, 2021
Feb 19, 2026