Taiwan FDA registration 83cfcde833e943607c9ca154ed9f88c6
Ilia High Sensitivity Zinfni Autologous Antibody Screening Reagent
TW: 宜立亞高感度辛夫尼自體抗體篩檢試劑
Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered Aug 03, 2022 – Aug 03, 2027ActiveRegistration details
- Analysis ID
- 83cfcde833e943607c9ca154ed9f88c6
- Customs Code
- DHA05603568808
Company information
- Manufacturer
- PHADIA AB;; PHADIA GMBH
- Manufacturer Country
- Sweden;;Germany
- Authorized Representative
- PHADIA TAIWAN INC.
Product details
- Intended Use
- This product is used for the in vitro qualitative determination of IgG antinuclear antibodies in human serum and plasma to assist in the clinical diagnosis of systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Schögren's syndrome, Scleroderma and polymyositis/dermatomyositis. This product is tested using the IgG method of Ifadia 100, Fadia 200 and Fadia 250 instruments.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5100 抗核抗體免疫試驗系統
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Aug 03, 2022
- Expiry Date
- Aug 03, 2027
About this record
Access comprehensive regulatory information for Ilia High Sensitivity Zinfni Autologous Antibody Screening Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 83cfcde833e943607c9ca154ed9f88c6 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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