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510(k) K160457

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch by Biofire Diagnostics, LLC — Product Code PEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2016
Date Received
February 19, 2016
Clearance Type
Special
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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  • K190341 — iC-GN iC-Cassette for use on the iC-System (June 28, 2019)
  • K182619 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (April 12, 2019)
  • K181493 — FilmArray Blood Culture Identification (BCID) Panel (July 5, 2018)
  • K143171 — FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2 (January 30, 2015)
  • K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) (January 8, 2014)
  • K130914 — FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL (June 21, 2013)