Roche Vantana cervical intraepithelial neoplasia cell test reagent - Taiwan Registration 7e7bf21999e54a5191fd8075ded51aec
Access comprehensive regulatory information for Roche Vantana cervical intraepithelial neoplasia cell test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7e7bf21999e54a5191fd8075ded51aec and manufactured by ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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Device Details
Registration Details
7e7bf21999e54a5191fd8075ded51aec
DHA05603623502
Product Details
This product is an immunocytochemistry reagent set for the simultaneous qualitative detection of p16INK4a and Ki-67 protein in Pap smears. Can be used to aid in differentiating women with high-grade cervical intraepithelial lesions in the screening population, as well as in subsets of patients with ASC-US (atypical squamous epithelial cells of undetermined significance) or LSIL (low-grade squamous intraepithelial cell lesions) Pap smear results, or those with a positive high-risk HPV test result.
B Hematology, pathology, and genetics
B.1865 ๅญๅฎฎ้ ธไธ็ฎๅ ง็คๆจฃ็ ่ฎ(CIN)่ฉฆ้ฉ็ณป็ตฑ
ๅง่จ่ฃฝ้ ;; ่ผธๅ ฅ;; QMS/QSD
Dates and Status
Nov 17, 2023
Nov 17, 2028