Taiwan FDA registration 376f4063701f70681c964c4bfae66510
FilmArray Torch
TW: 微晶多標的核酸自動化檢測系統
Taiwan·Risk Class 2·MD·BIOFIRE DIAGNOSTICS, LLC·Registered Nov 30, 2018 – Nov 30, 2028ActiveRegistration details
- Analysis ID
- 376f4063701f70681c964c4bfae66510
- License Form
- Ministry of Health Medical Device Import No. 031815
- Customs Code
- DHA05603181508
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 an automated in vitro diagnostic device that needs to be used with the FilmArray reagent set to detect multiple nucleic acid targets in clinical specimens.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A2570 Clinical Multi-standard Detection System Instrument
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 30, 2018
- Expiry Date
- Nov 30, 2028
About this record
Access comprehensive regulatory information for FilmArray Torch in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 376f4063701f70681c964c4bfae66510 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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