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Ilia Ro52 antibody detection reagent - Taiwan Registration c01140e867d0fb8aeca21c58cbe1b715

Access comprehensive regulatory information for Ilia Ro52 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 c01140e867d0fb8aeca21c58cbe1b715 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..

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c01140e867d0fb8aeca21c58cbe1b715
Registration Details
Taiwan FDA Registration: c01140e867d0fb8aeca21c58cbe1b715
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Device Details

Ilia Ro52 antibody detection reagent
TW: ๅฎœ็ซ‹ไบžRo52ๆŠ—้ซ”ๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2

Registration Details

c01140e867d0fb8aeca21c58cbe1b715

DHA00602470007

Company Information

Sweden;;Germany

Product Details

This product is used in Fadia 100, Fadia 200 and Fadia 250 instruments for the quantitative determination of IgG antibodies of Ro52 in human serum and plasma in vitro. A tool to assist in the clinical diagnosis of Schogren's syndrome and systemic lupus erythematosus (SLE).

C Immunology and microbiology

C.5100 ๆŠ—ๆ ธๆŠ—้ซ”ๅ…็–ซ่ฉฆ้ฉ—็ณป็ตฑ

import

Dates and Status

May 24, 2013

May 24, 2028