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510(k) K193519

BioFire Blood Culture Identification 2 (BCID2) Panel by Biofire Diagnostics, LLC — Product Code PEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2020
Date Received
December 19, 2019
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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Other clearances for product code PEN

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  • K213236 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (April 27, 2022)
  • 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)
  • K160457 — FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch (March 15, 2016)
  • 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)