Biofire Diagnostics, LLC - FDA 510(k) Cleared Devices

Biofire Diagnostics, LLC specializes in microbiology diagnostic systems for syndromic infectious disease testing. The company, with a manufacturing facility in Salt Lake City, develops rapid molecular diagnostic platforms that detect viruses, bacteria, parasites, yeast, and antimicrobial resistance genes. The BIOFIRE® FILMARRAY® System and BIOFIRE® SPOTFIRE® System deliver results in approximately one hour.

Biofire Diagnostics has received 24 FDA 510(k) clearances from 28 total submissions since its first clearance in 2015. The company maintains 100% focus on microbiology devices, with its latest FDA 510(k) clearance in 2025, demonstrating continued regulatory activity and product innovation.

Recent cleared devices include respiratory, gastrointestinal, blood culture identification, pneumonia, and meningitis/encephalitis diagnostic panels. The company's product portfolio addresses critical clinical needs including sepsis diagnosis, antimicrobial stewardship, and rapid pathogen identification in both laboratory and point-of-care settings.

Explore the complete list of device names, product codes, and individual clearance dates in the 510(k) database.

510(k) submissions have been managed by bioMerieux, Inc. as regulatory consultant.