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Iria tissue transglutaminase IgA antibody detection reagent - Taiwan Registration c8258bbb949c18d4e34b2cfc8df547f9

Access comprehensive regulatory information for Iria tissue transglutaminase 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 c8258bbb949c18d4e34b2cfc8df547f9 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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c8258bbb949c18d4e34b2cfc8df547f9
Registration Details
Taiwan FDA Registration: c8258bbb949c18d4e34b2cfc8df547f9
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Device Details

Iria tissue transglutaminase IgA antibody detection reagent
TW: ๅฎœ็ซ‹ไบž็ต„็น”ๆ€ง่ฝ‰้บฉๆฐจ้…ถIgAๆŠ—้ซ”ๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2

Registration Details

c8258bbb949c18d4e34b2cfc8df547f9

DHA05603367301

Company Information

Sweden;;Germany

Product Details

This product is used for the in vitro quantitative determination of IgA antibodies against tissue transglutamine (tTG) in human serum and plasma to assist patients with clinical diagnosis of celiac disease, using the Ilia IgA method in the Fadia 100, Fadia 200 and Fadia 250 instruments.

C Immunology and microbiology

C.5660 ๅคš็™ผๆ€ง่‡ช้ซ”ๆŠ—้ซ”ๅ…็–ซ่ฉฆ้ฉ—็ณป็ตฑ

Input;; QMS/QSD

Dates and Status

Sep 18, 2020

Sep 18, 2025