"Emu Const" immunofluorescence anti-mitochondria, anti-gastric parietal cells and anti-smooth muscle autologous antibody detection reagent
Taiwan·Risk Class 2·IMMUNO CONCEPTS, N.A. LTD·Registered Apr 16, 2021 – Apr 16, 2026Expired- Analysis ID
- 9d582404a424d03b370e2defd9d77fbe
- Customs Code
- DHA05603439402
- Manufacturer
- IMMUNO CONCEPTS, N.A. LTD
- Manufacturer Country
- United States
- Authorized Representative
- EVERLIGHT BIOTECH(TAIWAN) CO., LTD.
- Intended Use
- Qualitative and semi-quantitative detection of autoimmune immunoglobulin G in human serum by indirect immunofluorescence antibody detection method with manual fluorescence microscopy or fluorescence instrument used in clinical use by "Yimu Const". This testing system is used to assist in the detection of antimitochondria (AMA), antiparietal cells (APCA) and antismooth muscle cells (AMA) associated with Type 1 autoimmune hepatitis, Primary biliary cholangitis, pernicious anemia/autoimmune gastritis. ASMA) autologous antibodies and other laboratory and clinical findings.
- 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
- Input;; QMS/QSD
- Registration Date
- Apr 16, 2021
- Expiry Date
- Apr 16, 2026
Access comprehensive regulatory information for "Emu Const" immunofluorescence anti-mitochondria, anti-gastric parietal cells and anti-smooth muscle autologous antibody detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9d582404a424d03b370e2defd9d77fbe and manufactured by IMMUNO CONCEPTS, N.A. LTD. The authorized representative in Taiwan is EVERLIGHT BIOTECH(TAIWAN) CO., LTD..
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