Data / Medical devices / Dengue Serological Reagents / United States
FDA-registered makers of Dengue Serological Reagents in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Dengue Serological Reagents (product code OSU). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Dengue Serological Reagents
- Product code
- OSU
- Country
- United States
Makers of Dengue Serological Reagents in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | April 8, 2011 | 0 | 0 | 0 | api.fda.gov |
| Inbios International, Inc. | Seattle, WA, United States | Manufacturer, Manufacturer for export | 1 | April 8, 2011 | 0 | 0 | 0 | api.fda.gov |
| Access Bio, Inc. | Monroe Township, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chembio Diagnostic Systems, Inc. | Medford, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chembio Diagnostic Systems | Bay Shore, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.