Taiwan FDA registration 5d29fbbfb4381fc647b23759803054a1
EliA ANA Positive Controls
TW: 宜立亞抗核抗體陽性品管液
Taiwan·Risk Class 2·MD·PHADIA AB·Registered May 07, 2015 – May 07, 2025ExpiredRegistration details
- Analysis ID
- 5d29fbbfb4381fc647b23759803054a1
- License Form
- Ministry of Health Medical Device Import No. 027331
- Customs Code
- DHA05602733100
Company information
- Manufacturer
- PHADIA AB
- Manufacturer Country
- Sweden
- Authorized Representative
- PHADIA TAIWAN INC.
Product details
- Intended Use
- Ilia Antinuclear Antibody Positive Tube Solution is used in laboratories to monitor the performance of antinuclear antibody (ANA) in vitro assays using the EliA IgG method on 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 07, 2015
- Expiry Date
- May 07, 2025
About this record
Access comprehensive regulatory information for EliA ANA 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 5d29fbbfb4381fc647b23759803054a1 and manufactured by PHADIA AB. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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