Data / Medical devices / Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (PQA): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (product code PQA, Class 2, 21 CFR 866.3975). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on October 21, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PQA
- Device class
- 2
- Regulation
- 866.3975
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Canada | 1 |
| Italy | 1 |
Makers of Vaginitis And Bacterial Vaginosis Nucleic Acid Detection 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 |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | March 6, 2023 | 0 | 2 | 0 | api.fda.gov |
| GeneOhm Sciences Canada, ULC. | Quebec, Canada | Manufacturer | 4 | March 6, 2023 | 0 | 0 | 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 |
| Copan Italia | BRESCIA Lombardy, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 21, 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.