# Source: BioFire Diagnostics Official Website and Product Labeling

**Type:** source
**Status:** Useful
**Confidence:** Medium
**Source Type:** Official Website
**URL:** https://www.biofiredx.com
**Publisher:** BioFire Diagnostics, LLC (a bioMérieux company)
**Accessed:** 2026-06-18
**Updated:** 2026-06-18

## Summary

BioFire's official websites and product labeling (biofiredx.com and the BioFire Defense product pages, plus bioMérieux's BioFire panel information sheets) describing the FilmArray syndromic-testing platform and the panel menu, including the FDA-cleared Global Fever Panel.

## Useful Claims

- BioFire Diagnostics, LLC is part of bioMérieux and lists a Salt Lake City address (515 Colorow Drive, Salt Lake City, UT 84108) on product labeling.
- The FilmArray platform (FilmArray 2.0 and Torch systems) runs self-contained multiplex-PCR pouches for syndromic infectious-disease testing.
- The BioFire Global Fever Panel is an FDA-cleared IVD detecting six fever-causing targets (including dengue, chikungunya, *Leptospira*, and *Plasmodium* species) directly from EDTA whole blood in about 50 minutes with roughly two minutes of hands-on time; labeling references a De Novo clearance (DEN200043).
- A research-use-only (RUO) Global Fever Panel detects a broader set of targets for surveillance and research.
- The published panel menu spans respiratory, gastrointestinal, blood culture identification, meningitis/encephalitis, and pneumonia testing.

## Reliability Notes

Official manufacturer pages and regulatory labeling are reliable for product specifications, regulatory status, and corporate identity, but are marketing/labeling material and not independent evaluations of clinical performance. Employee counts, revenue, and acquisition history are not established by these pages and require separate primary sources. Product availability varies by country.

## Related Pages

- [BioFire Diagnostics](biofire-diagnostics.md)