Xpert HCV Viral Load - Taiwan Registration 099c87ec0e0a708a14eda9ed63b5c9d1
Access comprehensive regulatory information for Xpert HCV Viral Load in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 099c87ec0e0a708a14eda9ed63b5c9d1 and manufactured by CEPHEID AB. The authorized representative in Taiwan is PROGRESSIVE GROUP INC..
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Device Details
Registration Details
099c87ec0e0a708a14eda9ed63b5c9d1
Ministry of Health Medical Device Import No. 031729
DHA05603172902
Product Details
This product is performed with the GeneXpert instrument system to quantify HCV RNA in serum or plasma (EDTA) of HCV-infected individuals. Using automated reverse transcription polymerase chain reaction (RT-PCR) assay and fluorescence to detect HCV RNA content, this product quantifies HCV genotypes 1 to 6 ranging from 10 to 100,000,000 IU/mL. This product test is not intended as a screening test for blood donors for HCV.
B Hematology and pathology devices
B4020 Analyze specific reagents
Imported from abroad
Dates and Status
Oct 16, 2018
Oct 16, 2028