Ilia High Sensitivity Zinfni Autologous Antibody Screening Reagent - Taiwan Registration 83cfcde833e943607c9ca154ed9f88c6
Access comprehensive regulatory information for Ilia High Sensitivity Zinfni Autologous Antibody Screening Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 83cfcde833e943607c9ca154ed9f88c6 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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Device Details
Registration Details
83cfcde833e943607c9ca154ed9f88c6
DHA05603568808
Product Details
This product is used for the in vitro qualitative determination of IgG antinuclear antibodies in human serum and plasma to assist in the clinical diagnosis of systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Schรถgren's syndrome, Scleroderma and polymyositis/dermatomyositis. This product is tested using the IgG method of Ifadia 100, Fadia 200 and Fadia 250 instruments.
C Immunology and microbiology
C.5100 ๆๆ ธๆ้ซๅ ็ซ่ฉฆ้ฉ็ณป็ตฑ
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Aug 03, 2022
Aug 03, 2027