FilmArray Pneumonia Panel Plus

Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System

BioFire Diagnostics, LLC

The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Pneumonia Panel Plus.

Pre-market Notification Details

Device IDK222601
510k NumberK222601
Device Name:FilmArray Pneumonia Panel Plus
ClassificationMers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System
Applicant BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City,  UT  84108
ContactKevin Bourzac
CorrespondentKevin Bourzac
BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City,  UT  84108
Product CodeQDS  
CFR Regulation Number866.4001 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-29
Decision Date2022-10-27

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.