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GliadinDP IgG antibody detection reagent - Taiwan Registration bc02df78aeb2e79de10d670bf6bb310c

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..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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bc02df78aeb2e79de10d670bf6bb310c
Registration Details
Taiwan FDA Registration: bc02df78aeb2e79de10d670bf6bb310c
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Device Details

GliadinDP IgG antibody detection reagent
TW: ๅฎœ็ซ‹ไบž GliadinDP IgGๆŠ—้ซ”ๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2

Registration Details

bc02df78aeb2e79de10d670bf6bb310c

DHA05603309408

Company Information

Sweden;;Germany

Product Details

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.

C Immunology and microbiology

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

import

Dates and Status

Dec 02, 2019

Dec 02, 2029