Taiwan FDA registration 23abedd7e7751e13c0db1f62a399a2a2

Iria thyroid peroxidase antibody detection reagent

TW: 宜立亞甲狀腺過氧化酶抗體檢測試劑

Taiwan·Risk Class 2·PHADIA AB;; PHADIA GMBH·Registered Jun 15, 2016 – Jun 15, 2026Expired

Registration details

Analysis ID: 23abedd7e7751e13c0db1f62a399a2a2
Customs Code: DHA05602844201

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 in vitro quantification to determine IgG antibodies to thyroid peroxidase (TPO) in human serum and plasma, thereby assisting in the clinical diagnosis of thyroid diseases such as autoimmune thyroiditis and Graves' disease. This product was tested using the IgG method of Ilia on the Fadia 200 and Fadia 250 instruments.
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 15, 2016
Expiry Date: Jun 15, 2026

About this record

Access comprehensive regulatory information for Iria thyroid peroxidase 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 23abedd7e7751e13c0db1f62a399a2a2 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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