Taiwan FDA registration e228d7433b6dc8d12f3e3838dadd77cf

FilmArray Blood Culture Identification Panel (BCID)

TW: 微晶血液培養鑑定多標的核酸檢測試劑組

Taiwan·Risk Class 2·MD·BIOFIRE DIAGNOSTICS, LLC·Registered Feb 14, 2017 – Feb 14, 2027Active

Registration details

Analysis ID: e228d7433b6dc8d12f3e3838dadd77cf
License Form: Ministry of Health Medical Device Import No. 029323
Customs Code: DHA05602932308

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 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).
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C9999 Other
Import Information: Imported from abroad

Dates and status

Registration Date: Feb 14, 2017
Expiry Date: Feb 14, 2027

About this record

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 Mérieux S.p.A. Taiwan Branch.

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