Data / Medical devices / Fungal Organisms, Nucleic Acid-Based Assay
Fungal Organisms, Nucleic Acid-Based Assay (PEO): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Fungal Organisms, Nucleic Acid-Based Assay (product code PEO, Class 2, 21 CFR 866.3365). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on June 4, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- PEO
- Device class
- 2
- Regulation
- 866.3365
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Germany | 1 |
| Spain | 1 |
Makers of Fungal Organisms, Nucleic Acid-Based Assay
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 | |
| Qiagen, GMBH | HILDEN North Rhine-Westphalia, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STAT-Dx Life, S.L. | Barcelona, Spain | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 4, 2024. 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.