Taiwan FDA registration 1122bc8c1d001ca867337e70d96c12e1
Gliadin DP IgA antibody detection reagent
TW: 宜立亞Gliadin DP IgA抗體檢測試劑
Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered Jan 07, 2021 – Jan 07, 2026ExpiredRegistration details
- Analysis ID
- 1122bc8c1d001ca867337e70d96c12e1
- Customs Code
- DHA05603418809
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 to gliadin in human serum and plasma to assist in the clinical diagnosis of celiac disease. This product is tested using the ILIA IgA method on 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
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jan 07, 2021
- Expiry Date
- Jan 07, 2026
About this record
Access comprehensive regulatory information for Gliadin DP 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 1122bc8c1d001ca867337e70d96c12e1 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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