Data / Medical devices / Bordetella Pertussis Dna Assay System
Bordetella Pertussis Dna Assay System (OZZ): 12 FDA-registered makers in 2 countries
12 establishments in 2 countries are registered with the FDA to make Bordetella Pertussis Dna Assay System (product code OZZ, Class 2, 21 CFR 866.3980). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on November 20, 2025, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OZZ
- Device class
- 2
- Regulation
- 866.3980
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Hungary | 1 |
Makers of Bordetella Pertussis Dna Assay System
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 |
|---|---|---|---|---|---|---|---|---|
| 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 | |
| Diamond Diagnostics Inc. | Budapest, Hungary | 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 20, 2025. 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.