Taiwan FDA registration 7b98033b81678f787798f7bb9cce9faa
cobas CMV
TW: 羅氏可霸斯巨細胞病毒量核酸檢驗試劑
Taiwan·Risk Class 2·MD·ROCHE MOLECULAR SYSTEMS, INC.·Registered Aug 29, 2016 – Aug 29, 2026ActiveRegistration details
- Analysis ID
- 7b98033b81678f787798f7bb9cce9faa
- License Form
- Ministry of Health Medical Device Import No. 028479
- Customs Code
- DHA05602847908
Company information
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- This product is used to detect and quantify cytomegalovirus (CMV) DNA in EDTA plasma using in vitro nucleic acid amplification with the cobas 6800 system.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3175 CMV serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 29, 2016
- Expiry Date
- Aug 29, 2026
About this record
Access comprehensive regulatory information for cobas CMV in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7b98033b81678f787798f7bb9cce9faa and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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