Taiwan FDA registration b8e08e22bce8fcb940ec4da52141b610

"Roche" Fantana DLL3 (SP347) Test Reagent (Unsterilized)

TW: “羅氏” 凡塔那 DLL3 (SP347) 檢驗試劑 (未滅菌)

Taiwan·Risk Class 1·ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.·Registered Aug 01, 2018 – Aug 01, 2028Active

Registration details

Analysis ID: b8e08e22bce8fcb940ec4da52141b610
Customs Code: DHA09401943405

Company information

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

Product details

Intended Use: Limit the classification and grading management of medical equipment "immunopathological histochemical reagents and sets (B.1860) the first level identification range.
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;; 委託製造

Dates and status

Registration Date: Aug 01, 2018
Expiry Date: Aug 01, 2028

About this record

Access comprehensive regulatory information for "Roche" Fantana DLL3 (SP347) Test Reagent (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b8e08e22bce8fcb940ec4da52141b610 and manufactured by ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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