GB HCV RealQuant PCR - Taiwan Registration bd66a4bc97ac7be10ee287d9bdbeb7d5
Access comprehensive regulatory information for GB HCV RealQuant PCR in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number bd66a4bc97ac7be10ee287d9bdbeb7d5 and manufactured by GENERAL BIOLOGICALS CORP.. The authorized representative in Taiwan is GENERAL BIOLOGICALS CORP..
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Device Details
Registration Details
bd66a4bc97ac7be10ee287d9bdbeb7d5
Ministry of Health Medical Device Manufacturing No. 004945
Product Details
This product is an in vitro nucleic acid amplification test (NAT) for the quantitative detection of RNA of hepatitis C virus (HCV) genotypes 1 to 6 in human serum or plasma (EDTA). The purpose of use of this product is not to be used as a test to screen blood or blood products for HCV, nor as a diagnostic test to confirm the presence of HCV infection, but to quantitatively detect the amount of HCV RNA in the specimen to understand the changes in the HCV RNA amount of the specimen at different time points of the patient.
B Hematology and pathology devices
B4020 Analyze specific reagents
Produced in Taiwan, China
Dates and Status
Jul 23, 2015
Jul 23, 2025