"凱杰" 人類 KRAS 基因突變檢驗試劑組 - Taiwan Registration aeb653efac3be575b4f2e2bdaa7a07d3
Access comprehensive regulatory information for "凱杰" 人類 KRAS 基因突變檢驗試劑組 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number aeb653efac3be575b4f2e2bdaa7a07d3 and manufactured by QIAGEN GMBH. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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Device Details
Product Details
本產品是一款即時定性PCR檢測套組,本產品搭配 Rotor-Gene Q MDx 儀器用於檢測 KRAS 致癌基因第 12 和 13 號密碼子中的 7 種體細胞突變. 本試劑組適合檢測從結腸直腸癌 (Colorectal Cancer· CRC) 或非小細胞肺癌 (Non-Small Cell Lung Cancer· NSCLC) 樣本的福馬林固定石蠟包埋 (Formalin-Fixed Paraffin-Embedded· FFPE) 組織中提取的DNA,這些樣本可透過切除術、粗針組織切片 (Core Needle Biopsy· CNB) 或細針吸取 (Fine Needle Aspiration· FNA) 採集. KRAS 基因中的體細胞突變是 CRC 人類表皮生長因子(Epidermal Growth Factor· EGFR) 靶向治療(例如 panitumumab 和 cetuximab) 耐藥性的潛在預測性生物標記. 依據 KRAS G12C 突變偵測結果,therascreen KRAS RGQ PCR Kit 也可用於輔助識別適合接受 sotorasib 治療的 NSCLC 患者. KRAS 基因中的體細胞突變還可作為其他 NSCLC 治療的潛在預測性生物標記,幫助做出治療決定.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
Input;; QMS/QSD
Dates and Status
Sep 22, 2023
Sep 22, 2028