FDA applicant
Biofire Diagnostics, LLC
FDA records 37 decisions for Biofire Diagnostics, LLC (Salt Lake City, UT) from 2013 to 2026: 33 510(k) clearances and 4 De Novo grants. Most are in product codes QOF (Multi-Target Respiratory Specimen Nucleic Acid…) and PCH (Gastrointestinal Pathogen Panel Multiplex…). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 34 predicates, 23 of them its own earlier devices. 34 recalls are linked to its devices.
FDA’s records also spell it “Biofire Diagnostics, Inc.”, “Biofire Diagnostics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biofire Diagnostics, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Biofire Diagnostics, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Biofire”
FDA records each applicant name separately; these may or may not be the same firm.