Taiwan FDA registration b76dc0d4d46854b1f371cc37dc22c542

Roche human epithelial factor receptor 2 protein rabbit monoclonal antibody

TW: 羅氏人類上皮因子接受體第2蛋白兔子單株抗體

Taiwan·Risk Class 3·ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.·Registered Aug 04, 2015 – Aug 04, 2025Expired

Registration details

Analysis ID: b76dc0d4d46854b1f371cc37dc22c542
Customs Code: DHA05602754200

Company information

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

Product details

Intended Use: 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).
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: Aug 04, 2015
Expiry Date: Aug 04, 2025

About this record

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.