"Kaijie" set of fibroblast growth factor receptor amplification reaction mutation detection kit - Taiwan Registration 2337d13d312d0460ff791d96942d206f
Access comprehensive regulatory information for "Kaijie" set of fibroblast growth factor receptor amplification reaction mutation detection kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 2337d13d312d0460ff791d96942d206f 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 an immediate quantitative reverse transcription PCR assay for the detection of two point mutations in exon 7 in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples obtained from formalin-fixed paraffin-embedded (FFPE) urinary tract epithelial tumor tissue (p.R248C[c.742C>T] and p. S249C [c.746C>G]), two point mutations in exon 10 (p.G370C[c.1108G>T], and p. Y373C [c.1118A>G]) and two fusion genes (FGFR3-TACC3v1 and FGFR3-TACC3v3) were qualitatively detected. This test is indicated to assist in the identification of urothelial cancer (UC) patients who are eligible for treatment with BALVERSA (erdafitinib) due to these changes.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Jan 07, 2021
Jan 07, 2026