Data / Medical devices / C. Difficile Toxin Gene Amplification Assay
C. Difficile Toxin Gene Amplification Assay (OZN): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make C. Difficile Toxin Gene Amplification Assay (product code OZN, Class 2, 21 CFR 866.3130). 12 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on August 28, 2026, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OZN
- Device class
- 2
- Regulation
- 866.3130
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Canada | 2 |
| Switzerland | 1 |
| Germany | 1 |
Makers of C. Difficile Toxin Gene Amplification 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 |
|---|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 2 | May 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 2 | September 12, 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 |
| GeneOhm Sciences Canada, ULC. | Quebec, Canada | Manufacturer | 1 | April 2, 2013 | 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 |
| Qiagen, GMBH | HILDEN North Rhine-Westphalia, Germany | Specification developer | 1 | April 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience Canada Inc. | Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 28, 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.