Taiwan FDA registration bc02df78aeb2e79de10d670bf6bb310c

GliadinDP IgG antibody detection reagent

TW: 宜立亞 GliadinDP IgG抗體檢測試劑

Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered Dec 02, 2019 – Dec 02, 2029Active

Registration details

Analysis ID: bc02df78aeb2e79de10d670bf6bb310c
Customs Code: DHA05603309408

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 IgG antibodies to gliadin in human serum and plasma to assist in the clinical diagnosis of celiac disease. This product is tested using the IgG method in the Fadia 100 and Fadia 250 instruments. Performance changes (new applicable models): See Chinese copy of the copy.
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: import

Dates and status

Registration Date: Dec 02, 2019
Expiry Date: Dec 02, 2029

About this record

Access comprehensive regulatory information for GliadinDP 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 bc02df78aeb2e79de10d670bf6bb310c and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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