510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243222Substantially Equivalent

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

Biofire Diagnostics, LLC (Biomerieux), Salt Lake City UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243222 is the FDA 510(k) clearance record for BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus), a class II device, cleared for Biofire Diagnostics, LLC (Biomerieux) on under FDA product code QDS (Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System). FDA's definition for product code QDS reads: "A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection...". FDA records list 2 510(k) clearances for Biofire Diagnostics, LLC (Biomerieux), from to . As of , FDA records show one recall naming K243222.

Clearance record

Decision date
Received
(30 days to decision)
Product code
QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
Regulation
21 CFR 866.4001
Device class
Class II
Review panel
Pathology
Applicant
Biofire Diagnostics, LLC (Biomerieux) 515 Colorow Dr., Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDS

Trailing 12 months

FDA records hold no clearances under product code QDS in the trailing twelve months.

FDA records show no clearances under product code QDS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QDS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260