Taiwan FDA registration ed093fbe35d698cbec2686041c681e3f

EliA APS Positive controls

TW: 宜立亞抗磷脂症候群陽性品管液
Taiwan flagTaiwan·Risk Class 2·MD·PHADIA AB·Registered May 22, 2015 – May 22, 2025Expired
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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