Taiwan FDA registration 30a11f1cdc751e9da5177c7316876860
FilmArray Respiratory Panel 2 (RP2)
TW: 微晶呼吸道病原體多標的核酸檢測第二代試劑組
Taiwan·Risk Class 2·MD·BIOFIRE DIAGNOSTICS, LLC·Registered Jan 11, 2019 – Jan 11, 2024ExpiredRegistration details
- Analysis ID
- 30a11f1cdc751e9da5177c7316876860
- License Form
- Ministry of Health Medical Device Import No. 032035
- Customs Code
- DHA05603203500
Company information
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Manufacturer Country
- United States
- Authorized Representative
- Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
Product details
- Intended Use
- This product is used with the multiplex nucleic acid test used by FilmArray 2.0 or FilmArray Torch system to qualitatively detect and identify a variety of respiratory viruses and bacterial nucleic acids for nasopharyngeal swabs (NPS) obtained by individuals suspected of respiratory tract infection.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3980 Multi-standard nucleic acid test reagent for respiratory viruses
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jan 11, 2019
- Expiry Date
- Jan 11, 2024
About this record
Access comprehensive regulatory information for FilmArray Respiratory Panel 2 (RP2) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 30a11f1cdc751e9da5177c7316876860 and manufactured by BIOFIRE DIAGNOSTICS, LLC. The authorized representative in Taiwan is Hong Kong Commercial Mérieux S.p.A. Taiwan Branch.
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