p16INK4a Qualitative Protein Test Kit - Vietnam Registration 2400655ĐKLH/BYT-HTTB
Access comprehensive regulatory information for p16INK4a Qualitative Protein Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400655ĐKLH/BYT-HTTB and manufactured by Ventana Medical Systems, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
2400655ĐKLH/BYT-HTTB
000.00.04.G18-230628-0006
CINtec® p16 Histology
06695248001 / 06695256001
Technical Details
CINtec p16 Histology is an immunohistochemistry test to detect the presence of the p16INK4a protein on tissue sections embedded in paraffin and fixed with formalin, prepared from cervical biopsy samples. The test is intended to be used in combination with standard Hematoxylin and Eosin (H&E) preparations from the same cervical biopsy sample to support increased diagnostic accuracy and the reproducibility of diagnosis of cervical intraepithelial neoplasia (CIN) grade 3. This product must be interpreted by a qualified histopathologist in conjunction with the corresponding H&E preparation and relevant clinical information and appropriate cervical biopsy specimen. This antibody is intended for in vitro diagnostic use (IVD).
Dates and Status
May 10, 2024