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Gliadin DP IgA antibody detection reagent - Taiwan Registration 1122bc8c1d001ca867337e70d96c12e1

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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1122bc8c1d001ca867337e70d96c12e1
Registration Details
Taiwan FDA Registration: 1122bc8c1d001ca867337e70d96c12e1
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Device Details

Gliadin DP IgA antibody detection reagent
TW: ๅฎœ็ซ‹ไบžGliadin DP IgAๆŠ—้ซ”ๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2

Registration Details

1122bc8c1d001ca867337e70d96c12e1

DHA05603418809

Company Information

Sweden;;Germany

Product Details

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.

C Immunology and microbiology

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

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Jan 07, 2021

Jan 07, 2026