Taiwan FDA registration c8258bbb949c18d4e34b2cfc8df547f9
Iria tissue transglutaminase IgA antibody detection reagent
TW: 宜立亞組織性轉麩氨酶IgA抗體檢測試劑
Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered Sep 18, 2020 – Sep 18, 2025ExpiredRegistration details
- Analysis ID
- c8258bbb949c18d4e34b2cfc8df547f9
- Customs Code
- DHA05603367301
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 quantitative determination of IgA antibodies against tissue transglutamine (tTG) in human serum and plasma to assist patients with clinical diagnosis of celiac disease, using the Ilia IgA method in the Fadia 100, Fadia 200 and Fadia 250 instruments.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5660 多發性自體抗體免疫試驗系統
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Sep 18, 2020
- Expiry Date
- Sep 18, 2025
About this record
Access comprehensive regulatory information for Iria tissue transglutaminase IgA antibody detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c8258bbb949c18d4e34b2cfc8df547f9 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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