Data / Medical devices / Fungal Organisms, Nucleic Acid-Based Assay / United States
FDA-registered makers of Fungal Organisms, Nucleic Acid-Based Assay in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Fungal Organisms, Nucleic Acid-Based Assay (product code PEO). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Fungal Organisms, Nucleic Acid-Based Assay
- Product code
- PEO
- Country
- United States
Makers of Fungal Organisms, Nucleic Acid-Based Assay in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Genmark Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | December 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Luminex Corporation | Northbrook, IL, United States | Manufacturer | 1 | June 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Biogx | Birmingham, AL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| BioFire Diagnostics, LLC | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integrated Dna Technologies, Inc. | Coralville, IA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.