Sistan Hepatitis C antibody rapid screening - Taiwan Registration 470cb8054f220b18c4b47de692c64ecf
Access comprehensive regulatory information for Sistan Hepatitis C antibody rapid screening in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 470cb8054f220b18c4b47de692c64ecf and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is KS-HONG Biotech Co., Ltd.
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Device Details
Registration Details
470cb8054f220b18c4b47de692c64ecf
DHA05603589602
Product Details
This product is a rapid immunochromatography method that can be used for qualitative detection of HCV-specific antibodies present in human serum, plasma or whole blood. This test is used for in vitro professional diagnostic purposes, and the purpose is to help patients with clinical symptoms of HCV infection to diagnose HCV infection early. It only provides preliminary screening results. More specific alternative diagnostic approaches should also be prescribed to confirm HCV infection. This product is not intended for self-testing.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Dec 30, 2022
Dec 30, 2027