Taiwan FDA registration 72d7be000e0af10b0b0d1058c43662ea

Roche fantana anti-ALK (D5F3) rabbit monoclonal antibody

TW: 羅氏凡塔那抗ALK(D5F3)兔子單株抗體

Taiwan·Risk Class 3·ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.·Registered Oct 21, 2013 – Oct 21, 2028Active

Registration details

Analysis ID: 72d7be000e0af10b0b0d1058c43662ea
Customs Code: DHA05602553108

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 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).
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.1860 Immunopathological histochemistry reagents and kits
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Oct 21, 2013
Expiry Date: Oct 21, 2028

About this record

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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