"Kaijie" PIK3CA amplification reaction mutation detection reagent set - Taiwan Registration e73fb621d9234bf4857bfa7da9fdee94
Access comprehensive regulatory information for "Kaijie" PIK3CA amplification reaction mutation detection reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number e73fb621d9234bf4857bfa7da9fdee94 and manufactured by QIAGEN GMBH. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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Device Details
Product Details
This product is a real-time qualitative PCR test that detects 11 mutations (exon 7: C420R; exon 9: E542K, E545A, E545D [1635G >] in the phosphatidylinositol 3 kinase catalyst unit ฮฑ (PIK3CA) gene using genomic DNA (gDNA) extracted from formalin-fixed, Paraffin-Embedded (FFPE) breast tumor tissueT], E545G, E545K, Q546E, Q546R; and exon 20: H1047L, H1047R, H1047Y). This product can be used as a companion diagnostic test to assist clinicians in identifying breast cancer patients who may be suitable for PIQRAY (alpelisib) treatment based on PIK3CA mutation detection results. Patients with one or more PIK3CA mutations in FFPE tissue specimens that produce positive test results for this product are eligible for PIQRAY (alpelisib) therapy.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
May 13, 2021
May 13, 2026