Abbott hepatitis B viral load test kit - Taiwan Registration 69ee2c62b18868e3ede44c1034200621
Access comprehensive regulatory information for Abbott hepatitis B 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 69ee2c62b18868e3ede44c1034200621 and manufactured by ABBOTT MOLECULAR INC.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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Device Details
Product Details
This product is an in vitro diagnostic reagent using polymerase chain reaction (PCR) technology and an automated Alinity m system to quantify the DNA content of hepatitis B virus (HBV) in human plasma or serum. This product is suitable for assisting the health management of patients with chronic hepatitis B virus infection during antiviral therapy. This product is designed to help assess and monitor the patient's response to treatment by measuring the DNA basal value of HBV and the viral load during treatment. The test results of this product must be interpreted in the context of relevant clinical and experimental studies. This product is not intended for HBV screening in blood, blood products, tissues, or organ donors, or as a diagnostic test to determine HBV infection.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
Input;; QMS/QSD
Dates and Status
Aug 17, 2020
Aug 17, 2025