Taiwan FDA registration 55bda4daba7f09b660adc7f834e77bd3

Roche Vantana Silver in Situ Hybridization BF Detection Reagent (Non-Sterile)

TW: "羅氏" 凡塔那銀色原位雜交 BF 偵測試劑(未滅菌)

Taiwan·Risk Class 1·VENTANA MEDICAL SYSTEMS, INC.·Registered Sep 23, 2024 – Sep 23, 2029Active

Registration details

Analysis ID: 55bda4daba7f09b660adc7f834e77bd3
Customs Code: DHA09402361103

Company information

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

Product details

Intended Use: It is limited to the first level of identification scope of the "Immunopathological Histochemical Reagents and Sets (B.1860)" for the classification and grading management measures of medical devices.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.1860 Immunopathological histochemistry reagents and kits
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Sep 23, 2024
Expiry Date: Sep 23, 2029

About this record

Access comprehensive regulatory information for Roche Vantana Silver in Situ Hybridization BF Detection Reagent (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 55bda4daba7f09b660adc7f834e77bd3 and manufactured by VENTANA MEDICAL SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.