Data / Medical devices / Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections (QEP): 22 FDA-registered makers in 10 countries
22 establishments in 10 countries are registered with the FDA to make Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections (product code QEP, Class 2, 21 CFR 866.3393). 13 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on July 8, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QEP
- Device class
- 2
- Regulation
- 866.3393
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Canada | 1 |
| United Kingdom | 1 |
| Germany | 1 |
| Switzerland | 1 |
| Sweden | 1 |
| Italy | 1 |
| Ireland | 1 |
| Malaysia | 1 |
| China | 1 |
Makers of Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| GeneOhm Sciences Canada, ULC. | Quebec, Canada | Manufacturer | 2 | April 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Binx Health, Ltd. | Trowbridge Wiltshire, United Kingdom | Manufacturer | 1 | April 27, 2020 | 0 | 0 | 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 |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 1 | January 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 1 | January 16, 2025 | 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 | |
| Cepheid AB | SOLNA Stockholm, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Diagnostics, Inc. | Murrieta, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Italia | BRESCIA Lombardy, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmac Medical Products | CASTLEREA Roscommon, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hochuen Medical Sdn. Bhd. | SENAI Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hochuen Medical Technology Co.,Ltd. | Shenzhen Guangdong, China | 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 July 8, 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.