Data / Medical devices / Dengue Serological Reagents
Dengue Serological Reagents (OSU): 6 FDA-registered makers in 1 country
6 establishments in 1 country are registered with the FDA to make Dengue Serological Reagents (product code OSU, Class 2, 21 CFR 866.3945). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on April 8, 2011, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OSU
- Device class
- 2
- Regulation
- 866.3945
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
Makers of Dengue Serological Reagents
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 |
|---|---|---|---|---|---|---|---|---|
| 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 April 8, 2011. 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.