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FDA 510(k)

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

K-Number: K243222 · 2024-11-06

ApplicantBiofire Diagnostics, LLC (Biomerieux)
Decision Date2024-11-06
Product CodeQDS
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) is a medical device manufactured by Biofire Diagnostics, LLC (Biomerieux). It received FDA 510(k) clearance on 2024-11-06 under approval number K243222. 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 BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)?

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) is a medical device that received FDA 510(k) clearance on 2024-11-06. It is manufactured by Biofire Diagnostics, LLC (Biomerieux). The 510(k) number is K243222.

When was BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) approved by the FDA?

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) received FDA 510(k) clearance on 2024-11-06, under approval number K243222.

What company makes BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)?

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) is manufactured by Biofire Diagnostics, LLC (Biomerieux).

What is the FDA product code for BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)?

The FDA product code for BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) is QDS.

Other Devices by Biofire Diagnostics, LLC (Biomerieux)

K243463BIOFIRE FILMARRAY Tropical Fever Panel

Related Devices (Code: QDS)

K181324FilmArray Pneumonia Panel plusBiofire Diagnostics, LLC K222601FilmArray Pneumonia Panel plusBiofire 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.

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