Taiwan FDA registration 47d427b81a1dcc03281fc5ca60d7f177
Lumipulse G HBsAg-Quant Confirmation
TW: 錄祕帕斯GB型肝炎病毒表面抗原確認試劑
Taiwan·Risk Class 3·MD·FUJIREBIO INC., HACHIOJI FACILITY·Registered Aug 07, 2018 – Aug 07, 2023ExpiredRegistration details
- Analysis ID
- 47d427b81a1dcc03281fc5ca60d7f177
- License Form
- Ministry of Health Medical Device Import No. 031403
- Customs Code
- DHA05603140301
Company information
- Manufacturer
- FUJIREBIO INC., HACHIOJI FACILITY
- Manufacturer Country
- Japan
- Authorized Representative
- Grand Marquis IVD CO., LTD.
Product details
- Intended Use
- This product is a confirmation reagent for the quantitative test reagent of hepatitis B virus surface antigen in the recording of the Pas GB hepatitis virus surface antigen quantitative test reagent, which is used to confirm the existence of human serum or plasma hepatitis B surface antigen (HBsAg).
- 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
- Aug 07, 2018
- Expiry Date
- Aug 07, 2023
About this record
Access comprehensive regulatory information for Lumipulse G HBsAg-Quant Confirmation in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 47d427b81a1dcc03281fc5ca60d7f177 and manufactured by FUJIREBIO INC., HACHIOJI FACILITY. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..
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