Biofire Diagnostics, LLC: FDA filings under this applicant name

FDA lists 24 510(k) clearances under the applicant name “Biofire Diagnostics, LLC” (first 2015, latest 2025), plus 4 De Novo decisions, across 10 product codes in 2 review panels. Median 510(k) review time under this name: 73 days. Since 2017 the median was 59 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under bioMérieux, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Biofire Diagnostics, LLC took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.

Top product codes

Review panels

• Microbiology (27)
• Clinical Chemistry (1)

Most recent Biofire Diagnostics, LLC 510(k) clearances

14 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

43 product recalls in 33 recall events; 28 initiated in the last five years. Most recent: 2026-06-24.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Biofire Diagnostics, LLC is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT03029299: Implementation Assessment and Clinical Utility of the FilmArray® Respiratory Panel (RP) EZ in a CLIA-waived Setting (Completed, started 2017-04-04)
• NCT02248285: Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study (Completed, started 2015-04)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Biofire Defense, LLC (8 510(k)s)
• Biofire Diagnostics, Inc. (7 510(k)s)
• Biofire Diagnostics, LLC (Biomerieux) (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Biofire Diagnostics, LLC?

FDA lists 24 510(k) clearances under the applicant name “Biofire Diagnostics, LLC” (first 2015, latest 2025), plus 4 De Novo decisions, across 10 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Biofire Diagnostics, LLC?

The median time from FDA receipt to decision across 510(k)s cleared under the name Biofire Diagnostics, LLC is 73 days. Since 2017: 59 days, versus 118 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Biofire Diagnostics, LLC?

The most frequent FDA product codes under this applicant name are PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, 5); PEN (Gram-Negative Bacteria And Associated Resistance Markers, 5); QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, 5).

Next steps

• See all 24 Biofire Diagnostics, LLC clearances with predicates and recalls
• Run predicate analysis for product code PCH, Biofire Diagnostics, LLC's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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