Taiwan FDA registration 14d296ecb0a8ad7e885c359e19a45d2e
EliA CCP Positive controls
TW: 宜立亞CCP陽性品管液
Taiwan·Risk Class 2·MD·PHADIA AB·Registered Nov 26, 2015 – Nov 26, 2025ExpiredRegistration details
- Analysis ID
- 14d296ecb0a8ad7e885c359e19a45d2e
- License Form
- Ministry of Health Medical Device Import No. 027912
- Customs Code
- DHA05602791204
Company information
- Manufacturer
- PHADIA AB
- Manufacturer Country
- Sweden
- Authorized Representative
- PHADIA TAIWAN INC.
Product details
- Intended Use
- Performance (new applicable models) change: Quality control of in vitro determination of anti-cyclic citrullinated antibody (CCP) using EliA IgG 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
- Nov 26, 2015
- Expiry Date
- Nov 26, 2025
About this record
Access comprehensive regulatory information for EliA CCP 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 14d296ecb0a8ad7e885c359e19a45d2e and manufactured by PHADIA AB. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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