Taiwan FDA registration 4216aed55f43c13cfd775b8e6b8ea811
Lumipulse HBcrAg Controls
TW: 錄秘帕斯B型肝炎病毒核心關連抗原品管液
Taiwan·Risk Class 2·MD·FUJIREBIO INC., HACHIOJI FACILITY·Registered Sep 26, 2018 – Sep 26, 2028ActiveRegistration details
- Analysis ID
- 4216aed55f43c13cfd775b8e6b8ea811
- License Form
- Ministry of Health Medical Device Import No. 031477
- Customs Code
- DHA05603147701
Company information
- Manufacturer
- FUJIREBIO INC., HACHIOJI FACILITY
- Manufacturer Country
- Japan
- Authorized Representative
- Grand Marquis IVD CO., LTD.
Product details
- Intended Use
- This product is used for the quality control of Hepatitis B virus core-related antigen (HBcrAg) by the Paz G system.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1660 Quality Control Materials (Analytical and Non-Analytical)
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Sep 26, 2018
- Expiry Date
- Sep 26, 2028
About this record
Access comprehensive regulatory information for Lumipulse HBcrAg Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4216aed55f43c13cfd775b8e6b8ea811 and manufactured by FUJIREBIO INC., HACHIOJI FACILITY. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..
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