Taiwan FDA registration 0b41479593ed2c37f3be77e74f922faf

Roche Fantana pan-TRK (EPR17341) test reagent (unsterilized)

TW: 羅氏凡塔那pan-TRK(EPR17341)檢驗試劑(未滅菌)

Taiwan·Risk Class 1·ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.·Registered Apr 16, 2019 – Apr 16, 2029Active

Registration details

Analysis ID: 0b41479593ed2c37f3be77e74f922faf
Customs Code: DHA09402031602

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: Contract manufacturing;; input

Dates and status

Registration Date: Apr 16, 2019
Expiry Date: Apr 16, 2029

About this record

Access comprehensive regulatory information for Roche Fantana pan-TRK (EPR17341) 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 0b41479593ed2c37f3be77e74f922faf and manufactured by ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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