FilmArray Respiratory Panel 2 (RP2) - Taiwan Registration 30a11f1cdc751e9da5177c7316876860
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 Mรฉrieux S.p.A. Taiwan Branch.
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Device Details
Registration Details
30a11f1cdc751e9da5177c7316876860
Ministry of Health Medical Device Import No. 032035
DHA05603203500
Product Details
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.
C Immunology and microbiology devices
C3980 Multi-standard nucleic acid test reagent for respiratory viruses
Imported from abroad
Dates and Status
Jan 11, 2019
Jan 11, 2024