Taiwan FDA registration 67e6cfcefff80f32249465d3c7e56542
cobas HCV
TW: 羅氏可霸斯全自動C型肝炎病毒量核酸檢驗組
Taiwan·Risk Class 3·MD·Roche Molecular Systems, Inc.·Registered Apr 26, 2018 – Apr 26, 2028ActiveRegistration details
- Analysis ID
- 67e6cfcefff80f32249465d3c7e56542
- License Form
- Ministry of Health Medical Device Import No. 030547
- Customs Code
- DHA05603054704
Company information
- Manufacturer
- Roche Molecular Systems, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- This product is an in vitro nucleic acid amplified diagnostic reagent for the detection and quantification of HCV RNA in EDTA plasma or serum of HCV-infected individuals, genotypes 1 to 6.
- 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
- Apr 26, 2018
- Expiry Date
- Apr 26, 2028
About this record
Access comprehensive regulatory information for cobas HCV in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 67e6cfcefff80f32249465d3c7e56542 and manufactured by Roche Molecular Systems, Inc.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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