Data / Medical devices / Somatic Gene Mutation Detection System / United States
FDA-registered makers of Somatic Gene Mutation Detection System in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Somatic Gene Mutation Detection System (product code OWD). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Somatic Gene Mutation Detection System
- Product code
- OWD
- Country
- United States
Makers of Somatic Gene Mutation Detection System in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer, Manufacturer for export | 0 | 5 | 6 | 0 | api.fda.gov | |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 0 | 5 | 0 | 0 | api.fda.gov | |
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Manufacturer, Manufacturer for export | 0 | 2 | 0 | 0 | api.fda.gov | |
| Entrogen, Inc | Woodland Hills, CA, United States | Manufacturer, Manufacturer for export | 0 | 1 | 0 | 0 | api.fda.gov | |
| Invivoscribe, Inc. | San Diego, CA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cepheid | Sunnyvale, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cepheid | Lodi, CA, United States | Manufacturer for export | 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.