Taiwan FDA registration 95a1bea943f5ebd7108f10837d5f3d48

"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·Risk Class 2·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Jul 18, 2024 – Jul 18, 2029Active

Registration details

Analysis ID: 95a1bea943f5ebd7108f10837d5f3d48
Customs Code: DHA05603709300

Company information

Manufacturer: EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG
Manufacturer Country: Germany
Authorized Representative: EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE)

Product details

Intended Use: 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.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.5660 多發性自體抗體免疫試驗系統
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Jul 18, 2024
Expiry Date: Jul 18, 2029

About this record

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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