Taiwan FDA registration 8f6250a2207e2c895b5267573abbc45c
COBAS AmpliPrep/COBAS TaqMan CMV Test
TW: 羅氏全自動達可巨細胞病毒量核酸檢驗試劑
Taiwan·Risk Class 2·MD·ROCHE MOLECULAR SYSTEMS, INC.·Registered Oct 08, 2014 – Oct 08, 2024ExpiredRegistration details
- Analysis ID
- 8f6250a2207e2c895b5267573abbc45c
- License Form
- Ministry of Health Medical Device Import No. 026713
- Customs Code
- DHA05602671306
Company information
- Manufacturer
- ROCHE MOLECULAR SYSTEMS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- ROCHE DIAGNOSTICS LTD.
Product details
- Intended Use
- This product needs to be used with COBAS AmpliPrep instrument for automatic sample extraction, and then use COBAS TaqMan Analyzer or COBAS TaqMan 48 Analyzer for nucleic acid amplification and detection to quantitatively detect CMV DNA in human EDTA plasma.
- 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
- Oct 08, 2014
- Expiry Date
- Oct 08, 2024
About this record
Access comprehensive regulatory information for COBAS AmpliPrep/COBAS TaqMan CMV Test in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8f6250a2207e2c895b5267573abbc45c and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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