IntelliPlex HCV Genotyping Kit - Taiwan Registration 6e3ebc8c7c00c30943e3dc76c4c9f844
Access comprehensive regulatory information for IntelliPlex HCV Genotyping Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6e3ebc8c7c00c30943e3dc76c4c9f844 and manufactured by PLEXBIO CO., LTD.. The authorized representative in Taiwan is PLEXBIO CO., LTD..
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Device Details
Registration Details
6e3ebc8c7c00c30943e3dc76c4c9f844
Ministry of Health Medical Device Manufacturing No. 006709
Product Details
This product is a qualitative in vitro diagnostic molecular detection reagent, used to distinguish 6 major genotypes (1 to 6) and 2 subtypes (1a and 1b) of hepatitis C virus (HCV) in samples from serum or plasma, and needs to be used with "Borhen" microdish cleaning machine and "Borhenium" fluorescence analyzer. This product is not intended for donation screening of blood, serum, plasma, or tissue samples, or diagnostic tests to confirm HCV infection.
B Hematology and pathology devices
B4020 Analyze specific reagents
Produced in Taiwan, China
Dates and Status
May 14, 2020
May 14, 2025