Taiwan FDA registration 2337d13d312d0460ff791d96942d206f

"Kaijie" set of fibroblast growth factor receptor amplification reaction mutation detection kit

TW: “凱杰” 纖維母細胞生長因子受體擴增反應突變檢驗試劑組

Taiwan·Risk Class 3·QIAGEN GMBH·Registered Jan 07, 2021 – Jan 07, 2026Expired

Registration details

Analysis ID: 2337d13d312d0460ff791d96942d206f
Customs Code: DHA05603418707

Company information

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

Product details

Intended Use: 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.
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: Jan 07, 2021
Expiry Date: Jan 07, 2026

About this record

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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