Taiwan FDA registration faf7a57012e0e7ace0e47c2d4dceacb6

Ilia thyroglobulin antibody detection reagent

TW: 宜立亞甲狀腺球蛋白抗體檢測試劑

Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered Jun 03, 2016 – Jun 03, 2026Expired

Registration details

Analysis ID: faf7a57012e0e7ace0e47c2d4dceacb6
Customs Code: DHA05602843705

Company information

Manufacturer: PHADIA AB;; PHADIA GMBH
Manufacturer Country: Sweden;;Germany
Authorized Representative: PHADIA TAIWAN INC.

Product details

Intended Use: The Ilia Thyroglobulin Antibody Assay is used for in vitro quantification of thyroglobulin (TG) IgG antibodies in human serum and plasma, thereby assisting in the clinical diagnosis of thyroid diseases such as autoimmune thyroiditis and Graves' disease. The Ilia Thyroglobulin Antibody Detection Reagent was detected using the IgG method in the Fadia 250 instrument.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5870 甲狀腺自體抗體免疫試驗系統
Import Information: import

Dates and status

Registration Date: Jun 03, 2016
Expiry Date: Jun 03, 2026

About this record

Access comprehensive regulatory information for Ilia thyroglobulin 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 faf7a57012e0e7ace0e47c2d4dceacb6 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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