Data / Medical devices / Dna Specimen Collection, Saliva
Dna Specimen Collection, Saliva (OYJ): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Dna Specimen Collection, Saliva (product code OYJ, Class 2, 21 CFR 862.1675). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on October 27, 2022, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OYJ
- Device class
- 2
- Regulation
- 862.1675
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Canada | 3 |
| Spain | 1 |
| Mexico | 1 |
Makers of Dna Specimen Collection, Saliva
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 |
|---|---|---|---|---|---|---|---|---|
| Dna Genotek, Inc. | Ottawa Ontario, Canada | Manufacturer | 6 | October 27, 2022 | 0 | 1 | 0 | api.fda.gov |
| 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 |
| Progenika Biopharma S.A. | Derio Vizcaya, Spain | Specification developer | 1 | October 27, 2022 | 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 | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L-D Tool & Die Division Of Madix Engineering | Ottawa Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orasure Technologies Inc. | Bethlehem, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southmedic, Inc. | BARRIE Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 27, 2022. 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.