Taiwan FDA registration 7e7bf21999e54a5191fd8075ded51aec

Roche Vantana cervical intraepithelial neoplasia cell test reagent

TW: 羅氏凡塔那子宮頸上皮內瘤樣病變細胞檢驗試劑

Taiwan·Risk Class 2·ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.·Registered Nov 17, 2023 – Nov 17, 2028Active

Registration details

Analysis ID: 7e7bf21999e54a5191fd8075ded51aec
Customs Code: DHA05603623502

Company information

Manufacturer: ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.
Manufacturer Country: United States;;Germany
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: 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.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.1865 子宮頸上皮內瘤樣病變(CIN)試驗系統
Import Information: 委託製造;; 輸入;; QMS/QSD

Dates and status

Registration Date: Nov 17, 2023
Expiry Date: Nov 17, 2028

About this record

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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