CINtec p16 Histology - Taiwan Registration b2db85e252eae70f4ff6c7fb6865eb52
Access comprehensive regulatory information for CINtec p16 Histology in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b2db85e252eae70f4ff6c7fb6865eb52 and manufactured by VENTANA MEDICAL SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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Device Details
Registration Details
b2db85e252eae70f4ff6c7fb6865eb52
Ministry of Health Medical Device Import No. 036190
DHA05603619006
Product Details
This product is an immunohistochemical staining method for the qualitative detection of p16INK4a protein in formalin-fixed, paraffin-embedded cervical biopsy tissue sections, which can be interpreted in conjunction with H&E stained slides prepared from the same cervical tissue specimen to help improve the accuracy of diagnosis of high-grade cervical intraepithelial neoplasia and consistency among observers.
B Hematology, pathology, and genetics
B1865 Cervical intraepithelial neoplasia (CIN) test system
Imported from abroad; GMP
Dates and Status
Jun 16, 2023
Jun 16, 2028