Ojet's antinuclear antibody test group - Taiwan Registration 8550608d68b9e38158f94a1e08f5b1da
Access comprehensive regulatory information for Ojet's antinuclear antibody test group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8550608d68b9e38158f94a1e08f5b1da and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The authorized representative in Taiwan is IN FUNG CO., LTD..
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Device Details
Product Details
This product is a membrane for semi-quantitative detection of autologous antibodies IgG against extractable nuclear antigens (ENAs), including: SS-A 52, SS-A 60, SS-B, RNP/SM, SM, Centromere B (central segment B), Jo-1, Scl-70 and ribosomal P proteins. This test can only be used in vitro to help diagnose rheumatoid autoimmune diseases.
C Immunology and microbiology
C.5100 ๆๆ ธๆ้ซๅ ็ซ่ฉฆ้ฉ็ณป็ตฑ
import
Dates and Status
Jul 31, 2012
Jul 31, 2027