Taiwan FDA registration 57b3f5801acb92336949f85e4b9f3033
Abbott "Marisi" hepatitis B surface antigen third-generation test reagent
TW: 亞培”妙芮絲”B型肝炎表面抗原第三代檢驗試劑
Registration details
- Analysis ID
- 57b3f5801acb92336949f85e4b9f3033
- Customs Code
- DHA00601174001
Company information
- Manufacturer
- DIASORIN S.P.A. UK BRANCH
- Manufacturer Country
- United Kingdom
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- Enzyme immunoassay for legal testing of hepatitis B virus surface antigen in human serum or plasma.
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.4020 Analysis of specific tests
- Import Information
- import
Dates and status
- Registration Date
- Aug 08, 2005
- Expiry Date
- Aug 06, 2027
About this record
Access comprehensive regulatory information for Abbott "Marisi" hepatitis B surface antigen third-generation test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 57b3f5801acb92336949f85e4b9f3033 and manufactured by DIASORIN S.P.A. UK BRANCH. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC 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