Taiwan FDA registration 0737235ba391b39f7bd7885f91de14c5

Roche human epithelial factor receptor second protein rabbit single plant primary antibody reagent

TW: 羅氏人類上皮因子接受體第二蛋白兔子單株一級抗體試劑

Taiwan·Risk Class 3·VENTANA MEDICAL SYSTEMS, INC.·Registered Aug 08, 2024 – Aug 08, 2029Active

Registration details

Analysis ID: 0737235ba391b39f7bd7885f91de14c5
Customs Code: DHA05603709708

Company information

Manufacturer: VENTANA MEDICAL SYSTEMS, INC.
Manufacturer Country: United States
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: 本產品是一種兔子單株抗體,可在 BenchMark ULTRA 儀器上搭配 ultraView Universal DAB Detection Kit,針對福馬林固定石蠟包埋的正常和腫瘤乳房組織切片,進行免疫組織化學 (IHC) 分析 HER2 抗原的半定量偵測. 這項 IHC 器材用於識別適合接受 Herceptin (IHC 3+ 或 IHC 2+/ISH 擴增)、KADCYLA (IHC 3+ 或 IHC 2+/ISH 擴增) 或 ENHERTU ( IHC 1+ 或 IHC 2+/ ISH 非擴增) 治療的乳癌病患.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.1860 Immunopathological histochemistry reagents and kits
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Aug 08, 2024
Expiry Date: Aug 08, 2029

About this record

Access comprehensive regulatory information for Roche human epithelial factor receptor second protein rabbit single plant primary antibody reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 0737235ba391b39f7bd7885f91de14c5 and manufactured by VENTANA MEDICAL SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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