Taiwan FDA registration 16926dc727a04a7abf67ecc2a22e7394
ACCESS HCV Ab V3
TW: 亞瑟斯C型肝炎病毒抗體檢驗試劑組 第三代
Taiwan·Risk Class 3·MD·BIO-RAD·Registered Dec 19, 2018 – Dec 19, 2028ActiveRegistration details
- Analysis ID
- 16926dc727a04a7abf67ecc2a22e7394
- License Form
- Ministry of Health Medical Device Import No. 031982
- Customs Code
- DHA05603198201
Company information
- Manufacturer
- BIO-RAD
- Manufacturer Country
- France
- Authorized Representative
- Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.)
Product details
- Intended Use
- Equipped with the Access immunoassay system, paramagnetic particles are used to legally detect hepatitis C virus antibodies in human serum or plasma by chemical cold light immunoassay.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B4020 Analyze specific reagents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 19, 2018
- Expiry Date
- Dec 19, 2028
About this record
Access comprehensive regulatory information for ACCESS HCV Ab V3 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 16926dc727a04a7abf67ecc2a22e7394 and manufactured by BIO-RAD. The authorized representative in Taiwan is Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.).
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