Abbotet Hepatitis C viral load test kit - Taiwan Registration 860bd26af3737081b5abe44a0fdd5fa9
Access comprehensive regulatory information for Abbotet Hepatitis C viral load test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 860bd26af3737081b5abe44a0fdd5fa9 and manufactured by ABBOTT MOLECULAR INC.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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
This product is an all-in-one test method using reverse transcription polymerase chain reaction (RT-PCR) method and using automated Alinity m system to detect and quantify ribonucleic acid (RNA) of hepatitis C virus (HCV) in human serum or plasma. This product can be used in combination with clinical manifestations and other laboratory markers for the clinical management of HCV infected patients undergoing antiviral therapy. This product can also be used as a diagnostic test to confirm active HCV infection. The interpretation of test results of this product is limited to all relevant clinical and laboratory findings. This product is not intended for HCV screening in blood, blood products, tissues, or organ donors.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
Input;; QMS/QSD
Dates and Status
Aug 17, 2020
Aug 17, 2025