Data / Medical devices / Somatic Gene Mutation Detection System
Somatic Gene Mutation Detection System (OWD): 10 FDA-registered makers in 3 countries
10 establishments in 3 countries are registered with the FDA to make Somatic Gene Mutation Detection System (product code OWD, Class 3). 8 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OWD
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 2 |
| Switzerland | 1 |
Makers of Somatic Gene Mutation 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 |
|---|---|---|---|---|---|---|---|---|
| Qiagen, GMBH | HILDEN North Rhine-Westphalia, Germany | Manufacturer | 0 | 5 | 1 | 0 | api.fda.gov | |
| 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 | |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | 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.