Vietnam MOH registration 2400655ĐKLH/BYT-HTTB

p16INK4a Qualitative Protein Test Kit

VN: Thuốc thử xét nghiệm định tính protein p16INK4a

Vietnam·Risk Class TTBYT Loại C·CINtec® p16 Histology·Ventana Medical Systems, Inc.·Registered May 10, 2024

Registration details

Analysis ID: 2400655ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230628-0006
Product Type: CINtec® p16 Histology
Product Code: 06695248001 / 06695256001

Company information

Manufacturer: Ventana Medical Systems, Inc.
Manufacturer Country: UNITED STATES
Product Owner: Ventana Medical Systems, Inc.
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: 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

Registration Date: May 10, 2024

About this record

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.

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