Taiwan FDA registration 136222c57138cb06736856ad9c3d5908
EliA RF Positive Controls
TW: 宜立亞類風濕因子陽性品管液
Taiwan·Risk Class 2·MD·PHADIA AB·Registered May 29, 2015 – May 29, 2025ExpiredRegistration details
- Analysis ID
- 136222c57138cb06736856ad9c3d5908
- License Form
- Ministry of Health Medical Device Import No. 027344
- Customs Code
- DHA05602734406
Company information
- Manufacturer
- PHADIA AB
- Manufacturer Country
- Sweden
- Authorized Representative
- PHADIA TAIWAN INC.
Product details
- Intended Use
- Performance (new models) changes: This product is designed to monitor the performance of in vitro measurements of rheumatoid factor (RF) using the EliA IgM or EliA IgA methodology on the Fadia 100, Fadia 200 and Fadia 250 instruments.
- 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
- May 29, 2015
- Expiry Date
- May 29, 2025
About this record
Access comprehensive regulatory information for EliA RF Positive Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 136222c57138cb06736856ad9c3d5908 and manufactured by PHADIA AB. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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