Taiwan FDA registration 88386cd1d4eaf9f4cb6c9baaab12f814
Lumipulse B．R．A．H．M．S PCT Controls
TW: 錄秘帕斯前降鈣素品管液
Taiwan·Risk Class 2·MD·FUJIREBIO, Inc., Hachioji Facility·Registered Dec 12, 2018 – Dec 12, 2028ActiveRegistration details
- Analysis ID
- 88386cd1d4eaf9f4cb6c9baaab12f814
- License Form
- Ministry of Health Medical Device Import No. 031966
- Customs Code
- DHA05603196603
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 to record the analysis of Lumipulse Brahms PCT in human serum or plasma by the Paz G system and monitor the accuracy of its test procedure.
- 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
- Dec 12, 2018
- Expiry Date
- Dec 12, 2028
About this record
Access comprehensive regulatory information for Lumipulse B．R．A．H．M．S PCT Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 88386cd1d4eaf9f4cb6c9baaab12f814 and manufactured by FUJIREBIO, Inc., Hachioji Facility. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..
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