"Emu Const" immunofluorescence anti-mitochondria, anti-gastric parietal cells and anti-smooth muscle autologous antibody detection reagent - Taiwan Registration 9d582404a424d03b370e2defd9d77fbe
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..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Product Details
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.
C Immunology and microbiology
C.5660 ๅค็ผๆง่ช้ซๆ้ซๅ ็ซ่ฉฆ้ฉ็ณป็ตฑ
Input;; QMS/QSD
Dates and Status
Apr 16, 2021
Apr 16, 2026