FilmArray 2.0 Instrument - Taiwan Registration 8b1c46824fac3f40f5ec7b05905b27f9
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 Mรฉrieux S.p.A. Taiwan Branch.
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Device Details
Registration Details
8b1c46824fac3f40f5ec7b05905b27f9
Ministry of Health Medical Device Import No. 027685
DHA05602768506
Product Details
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.
A Clinical chemistry and clinical toxicology
A2570 Clinical Multi-standard Detection System Instrument
Imported from abroad
Dates and Status
Sep 15, 2015
Sep 15, 2025