Data / Medical devices / Covid-19 Multi-Analyte Antigen Device / United States
FDA-registered makers of Covid-19 Multi-Analyte Antigen Device in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Covid-19 Multi-Analyte Antigen Device (product code QMN). 0 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Covid-19 Multi-Analyte Antigen Device
- Product code
- QMN
- Country
- United States
Makers of Covid-19 Multi-Analyte Antigen Device 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 | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | San Diego, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| CorDx, Inc. | Alpharetta, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Quidel Corp. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scantibodies Laboratory, Inc. | Santee, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wondfo USA Co., Ltd. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| iHealth Manufacturing Inc | Irwindale, CA, 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.