Taiwan FDA registration 6bcc8650b1dab12fcf013ebeec0865da
FilmArray Respiratory Panel (RP)
TW: 微晶呼吸道病原體多標的核酸檢測試劑組
Taiwan·Risk Class 2·MD·BIOFIRE DIAGNOSTICS, LLC·Registered Mar 17, 2016 – Mar 17, 2021CancelledRegistration details
- Analysis ID
- 6bcc8650b1dab12fcf013ebeec0865da
- License Form
- Ministry of Health Medical Device Import No. 028304
- Customs Code
- DHA05602830402
Company information
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Manufacturer Country
- United States
- Authorized Representative
- Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
Product details
- 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
- Mar 17, 2016
- Expiry Date
- Mar 17, 2021
- Cancellation Date
- Sep 08, 2023
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for FilmArray Respiratory Panel (RP) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6bcc8650b1dab12fcf013ebeec0865da 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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