Taiwan FDA registration 7c149334f00b3713dc147d3017333067
Ilia tissue transglutaminase IgG antibody detection reagent
TW: 宜立亞組織性轉麩氨酶IgG抗體檢測試劑
Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered Jan 13, 2021 – Jan 13, 2026ExpiredRegistration details
- Analysis ID
- 7c149334f00b3713dc147d3017333067
- Customs Code
- DHA05603419101
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 semi-quantitative determination of IgG antibodies against tissue transglutase (tTG) in human serum and plasma. This product uses human recombinant tissue transglutaminase as an antigen to assist in the clinical diagnosis of patients with celiac disease. 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.5660 多發性自體抗體免疫試驗系統
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jan 13, 2021
- Expiry Date
- Jan 13, 2026
About this record
Access comprehensive regulatory information for Ilia tissue transglutaminase IgG 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 7c149334f00b3713dc147d3017333067 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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