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FDA 510(k)

FilmArray Pneumonia Panel plus

K-Number: K222601 · 2022-10-27

ApplicantBiofire Diagnostics, LLC
Decision Date2022-10-27
Product CodeQDS
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

FilmArray Pneumonia Panel plus is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2022-10-27 under approval number K222601. The device is classified under product code QDS. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FilmArray Pneumonia Panel plus?

FilmArray Pneumonia Panel plus is a medical device that received FDA 510(k) clearance on 2022-10-27. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K222601.

When was FilmArray Pneumonia Panel plus approved by the FDA?

FilmArray Pneumonia Panel plus received FDA 510(k) clearance on 2022-10-27, under approval number K222601.

What company makes FilmArray Pneumonia Panel plus?

FilmArray Pneumonia Panel plus is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for FilmArray Pneumonia Panel plus?

The FDA product code for FilmArray Pneumonia Panel plus is QDS.

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 K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch K160068FilmArray Respiratory Panel (RP) for use with FilmArray Torch DEN170017FilmArray Respiratory Panel 2 plus (RP2plus)

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Related Devices (Code: QDS)

K181324FilmArray Pneumonia Panel plusBiofire Diagnostics, LLC K243222BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)Biofire Diagnostics, LLC (Biomerieux)

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.

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