Data / Medical devices / Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System / United States
FDA-registered makers of Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (product code PQA). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
- Product code
- PQA
- Country
- United States
Makers of Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | March 6, 2023 | 0 | 2 | 0 | api.fda.gov |
| Cepheid | Sunnyvale, CA, United States | Manufacturer | 3 | October 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer | 3 | October 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer | 3 | November 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer | 1 | July 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 1 | July 16, 2026 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.