Taiwan FDA registration ed093fbe35d698cbec2686041c681e3f
EliA APS Positive controls
TW: 宜立亞抗磷脂症候群陽性品管液
Registration details
- Analysis ID
- ed093fbe35d698cbec2686041c681e3f
- License Form
- Ministry of Health Medical Device Import No. 027339
- Customs Code
- DHA05602733900
Company information
- Manufacturer
- PHADIA AB
- Manufacturer Country
- Sweden
- Authorized Representative
- PHADIA TAIWAN INC.
Product details
- Intended Use
- This product is used to monitor the performance of cardiolipin and β2-glycoprotein I antibodies during in vitro assays on the Fadia 100 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 22, 2015
- Expiry Date
- May 22, 2025
About this record
Access comprehensive regulatory information for EliA APS 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 ed093fbe35d698cbec2686041c681e3f and manufactured by PHADIA AB. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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