Data / Medical devices / C. Difficile Toxin Gene Amplification Assay / United States
FDA-registered makers of C. Difficile Toxin Gene Amplification Assay in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make C. Difficile Toxin Gene Amplification Assay (product code OZN). 9 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
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- Device
- C. Difficile Toxin Gene Amplification Assay
- Product code
- OZN
- Country
- United States
Makers of C. Difficile Toxin Gene Amplification Assay in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 2 | May 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer, Manufacturer for export | 2 | September 12, 2017 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 2 | September 12, 2017 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | April 2, 2013 | 0 | 2 | 0 | api.fda.gov |
| Cepheid | Sunnyvale, CA, United States | Manufacturer, Specification developer | 1 | February 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer | 1 | February 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer | 1 | February 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Luminex Corporation | Northbrook, IL, United States | Manufacturer | 1 | December 5, 2012 | 0 | 4 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 1 | November 22, 2017 | 0 | 1 | 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.