Data / Medical devices / Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies / United States
FDA-registered makers of Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies (product code NWY). 0 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
- Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
- Product code
- NWY
- Country
- United States
Makers of Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Easy Biotech Inc | Belmont, MA, 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 | |
| CTK Biotech, Inc. | Poway, CA, 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 | |
| Lumiquick Diagnostics, Inc. | Santa Clara, 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.