Taiwan FDA registration e73fb621d9234bf4857bfa7da9fdee94

"Kaijie" PIK3CA amplification reaction mutation detection reagent set

TW: “凱杰”PIK3CA擴增反應突變檢驗試劑組

Taiwan·Risk Class 3·QIAGEN GMBH·Registered May 13, 2021 – May 13, 2026Expired

Registration details

Analysis ID: e73fb621d9234bf4857bfa7da9fdee94
Customs Code: DHA05603465208

Company information

Manufacturer: QIAGEN GMBH
Manufacturer Country: Germany
Authorized Representative: QIAGEN TAIWAN COMPANY LIMITED

Product details

Intended Use: 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 α (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.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: May 13, 2021
Expiry Date: May 13, 2026

About this record

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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