Taiwan FDA registration 099c87ec0e0a708a14eda9ed63b5c9d1
Xpert HCV Viral Load
TW: 艾斯柏特C型肝炎病毒檢測試劑組
Taiwan·Risk Class 3·MD·CEPHEID AB·Registered Oct 16, 2018 – Oct 16, 2028ActiveRegistration details
- Analysis ID
- 099c87ec0e0a708a14eda9ed63b5c9d1
- License Form
- Ministry of Health Medical Device Import No. 031729
- Customs Code
- DHA05603172902
Company information
- Manufacturer
- CEPHEID AB
- Manufacturer Country
- Sweden
- Authorized Representative
- PROGRESSIVE GROUP INC.
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B4020 Analyze specific reagents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 16, 2018
- Expiry Date
- Oct 16, 2028
About this record
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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