Roche fantana anti-ALK (D5F3) rabbit monoclonal antibody - Taiwan Registration 72d7be000e0af10b0b0d1058c43662ea
Access comprehensive regulatory information for Roche fantana anti-ALK (D5F3) 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 72d7be000e0af10b0b0d1058c43662ea and manufactured by ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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Device Details
Registration Details
72d7be000e0af10b0b0d1058c43662ea
DHA05602553108
Product Details
This product is intended for laboratory use to detect anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded non-small cell lung cancer (NSCLC) tissues on the BenchMark GX/XT/ULTRA Automated Immunohistochemical Staining and in Situ Hybrid Staining (IHC/ISH) instrument. THIS ANTIBODY CAN ASSIST IN SCREENING PATIENTS WHO ARE SUITABLE FOR TREATMENT WITH XALKORI (CRIZOTINIB), ZYKADIA (CERITINIB) OR ALECENSA (ALECTINIB).
B Hematology, pathology, and genetics
B.1860 Immunopathological histochemistry reagents and kits
Input;; Contract manufacturing
Dates and Status
Oct 21, 2013
Oct 21, 2028