Taiwan FDA registration 6e3ebc8c7c00c30943e3dc76c4c9f844
IntelliPlex HCV Genotyping Kit
TW: 博錸C型肝炎病毒基因分型檢測試劑套組
Taiwan·Risk Class 2·MD·PLEXBIO CO., LTD.·Registered May 14, 2020 – May 14, 2025ExpiredRegistration details
- Analysis ID
- 6e3ebc8c7c00c30943e3dc76c4c9f844
- License Form
- Ministry of Health Medical Device Manufacturing No. 006709
Company information
- Manufacturer
- PLEXBIO CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- PLEXBIO CO., LTD.
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B4020 Analyze specific reagents
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- May 14, 2020
- Expiry Date
- May 14, 2025
About this record
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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