FilmArray Blood Culture Identification Panel (BCID) - Taiwan Registration e228d7433b6dc8d12f3e3838dadd77cf
Access comprehensive regulatory information for FilmArray Blood Culture Identification Panel (BCID) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e228d7433b6dc8d12f3e3838dadd77cf 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
e228d7433b6dc8d12f3e3838dadd77cf
Ministry of Health Medical Device Import No. 029323
DHA05602932308
Product Details
This product is equipped with the FilmArray system, which uses multiple nucleic acid sequence qualitative detection to simultaneously detect and identify the nucleic acids of a variety of bacteria and yeasts in the sample, as well as the genetic determinants of specific antibiotic resistance, and is suitable for blood culture samples that are directly recognized as positive using a continuous monitoring blood culture system (using Gram staining to confirm the presence of microorganisms).
C Immunology and microbiology devices
C9999 Other
Imported from abroad
Dates and Status
Feb 14, 2017
Feb 14, 2027