FDA 510(k)

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch

K-Number: K160457 · 2016-03-15

Decision Date2016-03-15

Product CodePEN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2016-03-15 under approval number K160457. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch?

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch is a medical device that received FDA 510(k) clearance on 2016-03-15. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K160457.

When was FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch approved by the FDA?

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch received FDA 510(k) clearance on 2016-03-15, under approval number K160457.

What company makes FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch?

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch?

The FDA product code for FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch is PEN.

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Other Devices by Biofire Diagnostics, LLC

K152579FilmArray Respiratory Panel EZ (RP EZ) K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch K160462FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch K160068FilmArray Respiratory Panel (RP) for use with FilmArray Torch DEN170017FilmArray Respiratory Panel 2 plus (RP2plus) K170604FilmArray Respiratory Panel 2 (RP2)

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Related Devices (Code: PEN)

K181493FilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC K190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc. K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated K193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenmark Diagnostics, Incorporated K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))Biofire Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.