Taiwan FDA registration 8b1c46824fac3f40f5ec7b05905b27f9
FilmArray 2.0 Instrument
TW: 微晶多標的自動化檢測儀
Taiwan·Risk Class 2·MD·BIOFIRE DIAGNOSTICS, LLC·Registered Sep 15, 2015 – Sep 15, 2025ExpiredRegistration details
- Analysis ID
- 8b1c46824fac3f40f5ec7b05905b27f9
- License Form
- Ministry of Health Medical Device Import No. 027685
- Customs Code
- DHA05602768506
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
- The FilmArray instrument is an automated in vitro diagnostic device used in combination with specific reagents to detect multiple nucleic acids in clinical samples. The instrument uses nested multiplex nucleic acid amplification target nucleic acid sequences in a closed system, and uses DNA melting analysis patterns, and the software automatically interprets the results and provides the detection report.
- 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
- Sep 15, 2015
- Expiry Date
- Sep 15, 2025
About this record
Access comprehensive regulatory information for FilmArray 2.0 Instrument in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8b1c46824fac3f40f5ec7b05905b27f9 and manufactured by BIOFIRE DIAGNOSTICS, LLC. The authorized representative in Taiwan is Hong Kong Commercial Mérieux S.p.A. Taiwan Branch.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices