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

Biofire Defense, LLC is a specialized molecular diagnostics and biothreat detection company with a manufacturing facility in Salt Lake City, US. Backed by bioMérieux, the company serves the U.S. Department of Defense, CDC, and public health agencies. BioFire Defense delivers fast, accurate PCR-based diagnostic solutions for infectious disease detection and biological threat identification.

The company has received 7 FDA 510(k) clearances from 9 total submissions since its first clearance in 2017. All submissions focus on Microbiology devices, reflecting the company's core expertise in molecular pathogen detection. The latest clearance in 2025 demonstrates continued regulatory activity and product innovation.

BioFire Defense specializes in syndromic testing panels and molecular diagnostic systems. Recent cleared devices include respiratory, gastrointestinal, and high-consequence infectious disease panels, along with external quality control kits. The company operates multiple platforms including point-of-care and high-throughput laboratory systems designed for clinical, military, and public health deployment.

Explore the complete list of FDA 510(k) cleared devices, product codes, and clearance dates in the database to learn more about BioFire Defense's regulatory submissions and device portfolio.

510(k) submissions have been managed by Biofire Defence, LLC as regulatory consultant.