Roche human epithelial factor receptor 2 protein rabbit monoclonal antibody - Taiwan Registration b76dc0d4d46854b1f371cc37dc22c542
Access comprehensive regulatory information for Roche human epithelial factor receptor 2 protein rabbit monoclonal antibody in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number b76dc0d4d46854b1f371cc37dc22c542 and manufactured by ROCHE DIAGNOSTICS GMBH;; 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.
Device Details
Registration Details
b76dc0d4d46854b1f371cc37dc22c542
DHA05602754200
Product Details
This product is used to semi-quantitatively detect HER2 antigen in formalin-fixed, paraffin-embedded normal and breast cancer tumor tissues on the Ventana autoimmune histochemical section stainer. This product can be used as an adjunct to assess the suitability of breast cancer patients for Herceptin, and can be used as an aid to assess the suitability of breast cancer patients for Kadcyla (trastuzumab emtansine) or Perjeta (pertuzumab).
B Hematology, pathology, and genetics
B.1860 Immunopathological histochemistry reagents and kits
Contract manufacturing;; input
Dates and Status
Aug 04, 2015
Aug 04, 2025