Data / Medical devices / Over-The-Counter Covid-19 Antigen Test / United States
FDA-registered makers of Over-The-Counter Covid-19 Antigen Test in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Over-The-Counter Covid-19 Antigen Test (product code QYT). 12 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
- Over-The-Counter Covid-19 Antigen Test
- Product code
- QYT
- Country
- United States
Makers of Over-The-Counter Covid-19 Antigen Test in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acon Laboratories, Inc. | San Diego, CA, United States | Manufacturer, Specification developer | 1 | November 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| Assure Tech LLC | Wilmington, DE, United States | Repackager or relabeler, Specification developer | 1 | June 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Abbott Diagnostics Scarborough, Inc. | Westbrook, ME, United States | Manufacturer | 1 | February 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Access Bio, Inc. | Monroe Township, NJ, United States | Manufacturer | 1 | January 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| CorDx, Inc. | Alpharetta, GA, United States | Manufacturer | 1 | June 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Genabio Diagnostics Inc | Bedford, MA, United States | Manufacturer, Specification developer | 1 | September 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 1 | April 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Inbios International, Inc. | Seattle, WA, United States | Complaint file establishment, Manufacturer | 1 | October 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Osang LLC | S Pasadena, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 1 | March 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 1 | March 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | March 22, 2024 | 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.