FDA applicant

Biofire Diagnostics, LLC (Biomerieux)

Salt Lake City, UT2 decisions2024–20243 recalls

FDA records 2 decisions for Biofire Diagnostics, LLC (Biomerieux) (Salt Lake City, UT) in 2024: 2 510(k) clearances. Most are in product codes QDS (Mers-Cov And Common Respiratory Pathogens…) and QMV (Device To Detect And Identify Selected…). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, pathology panel, where it files most

How often FDA has decided Biofire Diagnostics, LLC (Biomerieux)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2024high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

2in 2026

2024high 2 (2026) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Biofire Diagnostics, LLC (Biomerieux) by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biofire Diagnostics, LLC (Biomerieux)’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Biofire”

FDA records each applicant name separately; these may or may not be the same firm.

Biofire Diagnostics, LLC 37 Biofire Defense, LLC 10

Biofire Diagnostics, LLC (Biomerieux)

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Biofire”