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510(k) K130914

FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL by Biofire Diagnostics, Inc. — Product Code PEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2013
Date Received
April 2, 2013
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)
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