Taiwan FDA registration b2db85e252eae70f4ff6c7fb6865eb52
CINtec p16 Histology
TW: 羅氏凡塔那子宮頸上皮內瘤樣病變病理檢驗試劑
Taiwan·Risk Class 2·MD·VENTANA MEDICAL SYSTEMS, INC.·Registered Jun 16, 2023 – Jun 16, 2028ActiveRegistration details
- Analysis ID
- b2db85e252eae70f4ff6c7fb6865eb52
- License Form
- Ministry of Health Medical Device Import No. 036190
- Customs Code
- DHA05603619006
Company information
- Manufacturer
- VENTANA MEDICAL SYSTEMS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B1865 Cervical intraepithelial neoplasia (CIN) test system
- Import Information
- Imported from abroad; GMP
Dates and status
- Registration Date
- Jun 16, 2023
- Expiry Date
- Jun 16, 2028
About this record
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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