Data / Medical devices / Trichomonas Vaginalis Nucleic Acid Amplification Test System / United States
FDA-registered makers of Trichomonas Vaginalis Nucleic Acid Amplification Test System in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Trichomonas Vaginalis Nucleic Acid Amplification Test System (product code OUY). 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
- Trichomonas Vaginalis Nucleic Acid Amplification Test System
- Product code
- OUY
- Country
- United States
Makers of Trichomonas Vaginalis Nucleic Acid Amplification Test System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hologic, Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 3 | November 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Sunnyvale, CA, United States | Manufacturer, Manufacturer for export | 2 | August 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer, Manufacturer for export | 2 | August 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | January 8, 2019 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 1 | August 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Molecular Distribution Center | Itasca, IL, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rpi Biosolutions | Mundelein, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visby Medical, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 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.