Data / Medical devices / Dna Specimen Collection, Saliva / United States
FDA-registered makers of Dna Specimen Collection, Saliva in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Dna Specimen Collection, Saliva (product code OYJ). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Dna Specimen Collection, Saliva
- Product code
- OYJ
- Country
- United States
Makers of Dna Specimen Collection, Saliva in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Labcorp Genetics | San Francisco, CA, United States | Specification developer | 2 | May 26, 2016 | 0 | 0 | 0 | api.fda.gov |
| 23andMe Genomics LLC | Palo Alto, CA, United States | Specification developer | 1 | February 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Color Diagnostics, LLC | South San Francisco, CA, United States | Specification developer | 1 | May 26, 2016 | 0 | 0 | 0 | api.fda.gov |
| Alom Technologies Corporation | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autogenomics, Incorporated | Carlsbad, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orasure Technologies Inc. | Bethlehem, PA, United States | Contract manufacturer | 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.