Data / Medical devices / Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections / United States
FDA-registered makers of Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections (product code QEP). 9 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- Product code
- QEP
- Country
- United States
Makers of Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections 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 | 4 | May 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer | 4 | May 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 4 | May 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Manufacturer, Manufacturer for export | 2 | March 3, 2023 | 0 | 1 | 0 | api.fda.gov |
| Abbott Molecular Distribution Center | Itasca, IL, United States | Manufacturer | 2 | March 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | April 22, 2025 | 0 | 1 | 0 | api.fda.gov |
| Cepheid | Sunnyvale, CA, United States | Manufacturer | 1 | May 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer | 1 | May 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Visby Medical, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | August 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Biogx | Birmingham, AL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Diagnostics, Inc. | Murrieta, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rpi Biosolutions | Mundelein, IL, United States | Contract manufacturer | 0 | 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.