Taiwan FDA registration 9a8a8635e09c7473434f0ea2978072e6

Roche Vantana PD-L1 (SP263) test set

TW: 羅氏凡塔那PD-L1(SP263)檢驗試劑組
Taiwan flagTaiwan·Risk Class 3·ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.·Registered Dec 03, 2018 – Dec 03, 2028Active
Registration details
Analysis ID
9a8a8635e09c7473434f0ea2978072e6
Customs Code
DHA05603181100
Company information
Manufacturer Country
United States;;Germany
Authorized Representative
ROCHE DIAGNOSTICS LTD.
Product details
Intended Use
For details, it is Chinese approved copy of the imitation order
Product Type (Level 1)
B Hematology, pathology, and genetics
Product Type (Level 2)
B.1860 Immunopathological histochemistry reagents and kits
Import Information
Contract manufacturing;; input
Dates and status
Registration Date
Dec 03, 2018
Expiry Date
Dec 03, 2028
About this record

Access comprehensive regulatory information for Roche Vantana PD-L1 (SP263) test set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 9a8a8635e09c7473434f0ea2978072e6 and manufactured by ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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