"歐蒙" 免疫膜條法自體免疫性發炎性皮肌病變系列 IgG 抗體檢測系統 16 與 cN-1A 和 HMGCR - Taiwan Registration 95a1bea943f5ebd7108f10837d5f3d48
Access comprehensive regulatory information for "歐蒙" 免疫膜條法自體免疫性發炎性皮肌病變系列 IgG 抗體檢測系統 16 與 cN-1A 和 HMGCR in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 95a1bea943f5ebd7108f10837d5f3d48 and manufactured by EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG. The authorized representative in Taiwan is EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE).
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Device Details
Product Details
本產品用於定性檢測人類血清或血漿中抗Mi-2α,Mi-2β,TIF1γ,MDA5,NXP2,SAE1, Ku,PM-Scl100,PM-Scl75,Jo-1,SRP,PL-7,PL-12,EJ,OJ,Ro-52,cN-1A與HMGCR等多種不同抗原IgG類抗體. 輔助診斷皮肌炎、多發性肌炎、抗合成酶綜合症、包涵體肌炎(IBM)、壞死性肌炎以及重疊綜合症,相關疾病診斷需結合病患臨床表徵.
C Immunology and microbiology
C.5660 多發性自體抗體免疫試驗系統
QMS/QSD;; 輸入
Dates and Status
Jul 18, 2024
Jul 18, 2029