Taiwan FDA registration 8ad0960f609ff229ae2709a801b16dcb

Roche human epithelial factor receptor second protein gene two-color in situ hybrid nucleic acid probe combination

TW: 羅氏人類上皮因子接受體第二蛋白質基因雙色原位雜交核酸探針組合
Taiwan flagTaiwan·Risk Class 3·ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.·Registered Dec 26, 2011 – Dec 26, 2021Cancelled
Registration details
Analysis ID
8ad0960f609ff229ae2709a801b16dcb
Customs Code
DHA00602311902
Company information
Manufacturer Country
United States;;Germany
Authorized Representative
ROCHE DIAGNOSTICS LTD.
Product details
Intended Use
The purpose of the Roche Human Epithelial Factor Receptor Second Protein Gene Two-color in Situ Hybrid Nucleic Acid Probe Combination is to quantify the amplification of human epithelial factor second protein (HER2) gene directly under light microscopy by formalin fixation and paraffin-embedded human breast cancer and gastric cancer tissue samples, including the gastroesophageal junction, with Roche Vantana automatic multifunctional histopathological staining system, using two-color in situ hybrid staining technology.
Product Type (Level 1)
B Hematology, pathology, and genetics
Product Type (Level 2)
B.1860 Immunopathological histochemistry reagents and kits
Import Information
Contract manufacturing;; input
Dates and status
Registration Date
Dec 26, 2011
Expiry Date
Dec 26, 2021
Cancellation Date
Sep 08, 2023
Cancellation information
Status
Logged out
Reason
未展延而逾期者
About this record

Access comprehensive regulatory information for Roche human epithelial factor receptor second protein gene two-color in situ hybrid nucleic acid probe combination in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 8ad0960f609ff229ae2709a801b16dcb and manufactured by ROCHE DIAGNOSTICS GMBH;; VENTANA MEDICAL SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

Free DatabasePowered by Pure Global AI89,000+ Devices