Biofire Diagnostics - FDA 510(k) Cleared Devices

Biofire Diagnostics, specializes in syndromic infectious disease diagnostics with a manufacturing facility in Salt Lake City, US. The company develops rapid molecular testing systems designed to identify multiple pathogens and antimicrobial resistance markers in a single assay.

Biofire Diagnostics has received 2 FDA 510(k) clearances from 2 total submissions, all in the Microbiology category. The company's regulatory history spans from 2014 to 2023. Note: The company is currently inactive with no clearances in more than five years and should be treated as a historical record.

The company's cleared devices include multiplex PCR panels targeting respiratory infections, gastrointestinal pathogens, blood culture identification, and other syndromic presentations. These systems are designed for rapid turnaround in clinical laboratory and point-of-care settings. Biofire Diagnostics is now part of bioMérieux, operating as a product franchise brand within the parent company's molecular diagnostics portfolio.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the 510(k) database.