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510(k) K143171

FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 by Biofire Diagnostics, LLC — Product Code PEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2015
Date Received
November 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram-Negative Bacteria And Associated Resistance Markers
Device Class
Class II
Regulation Number
866.3365
Review Panel
MI
Submission Type

A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.

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  • K181493 — FilmArray Blood Culture Identification (BCID) Panel (July 5, 2018)
  • K160457 — FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch (March 15, 2016)
  • K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) (January 8, 2014)
  • K130914 — FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL (June 21, 2013)