Data / Medical devices / Bordetella Pertussis Dna Assay System / United States
FDA-registered makers of Bordetella Pertussis Dna Assay System in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Bordetella Pertussis Dna Assay System (product code OZZ). 5 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
- Bordetella Pertussis Dna Assay System
- Product code
- OZZ
- Country
- United States
Makers of Bordetella Pertussis Dna Assay System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer | 1 | August 13, 2018 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 1 | March 25, 2014 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 1 | July 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer | 1 | November 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 1 | November 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Applied BioCode, Inc. | Santa Fe Springs, CA, United States | Complaint file establishment, Manufacturer | 0 | 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 | |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luminex Corporation | Austin, TX, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Luminex Corporation | Northbrook, IL, United States | Complaint file establishment, 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.