Taiwan FDA registration fa3a6b554c0ec53e76e56238de34b9eb
EliA IgM Calibrators
TW: 宜立亞IgM校正試劑組
Taiwan·Risk Class 2·MD·PHADIA AB·Registered Sep 01, 2015 – Sep 01, 2025ExpiredRegistration details
- Analysis ID
- fa3a6b554c0ec53e76e56238de34b9eb
- License Form
- Ministry of Health Medical Device Import No. 027566
- Customs Code
- DHA05602756601
Company information
- Manufacturer
- PHADIA AB
- Manufacturer Country
- Sweden
- Authorized Representative
- PHADIA TAIWAN INC.
Product details
- Intended Use
- The performance (newly applicable models) has been changed to: this product is equipped with Fadia 100, Fadia 200 and Fadia 250 instruments, the ILIA IgM Correction Solution/Ilia IgM Correction Sheet needs to use the ILIA IgM calibration microwell groove to establish the IgM correction curve to analyze the patient specimen, and the ILIA IgM Correction Curve Quality Tube Fluid/ILIA IgM Correction Curve Piece uses the ilivia IgM correction microwell groove to control the effectiveness of the IgM correction curve.
- 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
- Sep 01, 2015
- Expiry Date
- Sep 01, 2025
About this record
Access comprehensive regulatory information for EliA IgM Calibrators in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fa3a6b554c0ec53e76e56238de34b9eb and manufactured by PHADIA AB. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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