Taiwan FDA registration b38cf62171dd4d3e71b896169cd20b1a
EliA ANCA/GBM Positive Controls
TW: 宜立亞ANCA/GBM陽性品管液
Taiwan·Risk Class 2·MD·PHADIA AB·Registered Aug 11, 2015 – Aug 11, 2025ExpiredRegistration details
- Analysis ID
- b38cf62171dd4d3e71b896169cd20b1a
- License Form
- Ministry of Health Medical Device Import No. 027547
- Customs Code
- DHA05602754707
Company information
- Manufacturer
- PHADIA AB
- Manufacturer Country
- Sweden
- Authorized Representative
- PHADIA TAIWAN INC.
Product details
- Intended Use
- This product is designed to monitor the performance of in vitro assays of ANCA/GBM antibodies using the ILIA IgG methodology in 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
- Aug 11, 2015
- Expiry Date
- Aug 11, 2025
About this record
Access comprehensive regulatory information for EliA ANCA/GBM 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 b38cf62171dd4d3e71b896169cd20b1a and manufactured by PHADIA AB. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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