Taiwan FDA registration e1d1dfee9f7e8414feb3cd26a07704d1
Lumipulse G CK-MB Calibrators set
TW: 錄秘帕斯G肌酸激酶MB同功酶校正液組
Taiwan·Risk Class 2·MD·FUJIREBIO, Inc., Hachioji Facility·Registered Dec 22, 2018 – Dec 22, 2028ActiveRegistration details
- Analysis ID
- e1d1dfee9f7e8414feb3cd26a07704d1
- License Form
- Ministry of Health Medical Device Import No. 031980
- Customs Code
- DHA05603198000
Company information
- Manufacturer
- FUJIREBIO, Inc., Hachioji Facility
- Manufacturer Country
- Japan
- Authorized Representative
- Grand Marquis IVD CO., LTD.
Product details
- Intended Use
- This product is specially designed for the calibration of Paz G creatine kinase MB isoenzyme assay reagent.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1150 calibrate
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 22, 2018
- Expiry Date
- Dec 22, 2028
About this record
Access comprehensive regulatory information for Lumipulse G CK-MB Calibrators set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e1d1dfee9f7e8414feb3cd26a07704d1 and manufactured by FUJIREBIO, Inc., Hachioji Facility. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..
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