Data / Medical devices / C. Difficile Nucleic Acid Amplification Test Assay / United States
FDA-registered makers of C. Difficile Nucleic Acid Amplification Test Assay in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make C. Difficile Nucleic Acid Amplification Test Assay (product code OMN). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- C. Difficile Nucleic Acid Amplification Test Assay
- Product code
- OMN
- Country
- United States
Makers of C. Difficile Nucleic Acid Amplification Test Assay in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cepheid | Sunnyvale, CA, United States | Manufacturer | 1 | April 7, 2011 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer | 1 | April 7, 2011 | 0 | 0 | 0 | api.fda.gov |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer | 1 | April 4, 2012 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 1 | July 9, 2010 | 0 | 2 | 0 | api.fda.gov |
| Planet Innovation Products, Inc. | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.