Elia High Sensitivity SmDP Ab Assay - Taiwan Registration 4351d49bb701bf02de87c98fd7840456
Access comprehensive regulatory information for Elia High Sensitivity SmDP Ab Assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4351d49bb701bf02de87c98fd7840456 and manufactured by PHADIA AB;; PHADIA GMBH. The authorized representative in Taiwan is PHADIA TAIWAN INC..
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Device Details
Registration Details
4351d49bb701bf02de87c98fd7840456
DHA05603620700
Product Details
This product is used for the quantitative detection of anti-Sm IgG antibodies in human serum and plasma in vitro to assist in the clinical diagnosis of systemic lupus-erythematosus (SLE). This product was tested using the Elia IgG method on the Fadia 100, Fadia 200 and Fadia 250 instruments.
C Immunology and microbiology
C.5100 ๆๆ ธๆ้ซๅ ็ซ่ฉฆ้ฉ็ณป็ตฑ
Input;; QMS/QSD
Dates and Status
Jul 31, 2023
Jul 31, 2028