Taiwan FDA registration 5667c6592180f00446bc625e0e23725d
Roche Cobas HBV/HCV/HIV-1 nucleic acid quality control group
TW: 羅氏可霸斯HBV/HCV/HIV-1核酸品管組
Taiwan·Risk Class 2·ROCHE MOLECULAR SYSTEMS, INC.·Registered Jan 26, 2022 – Jan 26, 2027ActiveRegistration details
- Analysis ID
- 5667c6592180f00446bc625e0e23725d
- Customs Code
- DHA05603521300
Company information
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- 本產品是搭配cobas HBV,cobas HCV與cobas HIV-1檢驗試劑使用於cobas 5800/6800/8800系統的陽性品管液.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Jan 26, 2022
- Expiry Date
- Jan 26, 2027
About this record
Access comprehensive regulatory information for Roche Cobas HBV/HCV/HIV-1 nucleic acid quality control group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5667c6592180f00446bc625e0e23725d and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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