Data / Medical devices / Dengue Virus Antigen Assay
Dengue Virus Antigen Assay (QCU): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Dengue Virus Antigen Assay (product code QCU, Class 2, 21 CFR 866.3945). 3 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 August 27, 2018, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QCU
- Device class
- 2
- Regulation
- 866.3945
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Germany | 1 |
| India | 1 |
Makers of Dengue Virus Antigen Assay
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 |
|---|---|---|---|---|---|---|---|---|
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 1 | August 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | August 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Inbios International, Inc. | Seattle, WA, United States | Manufacturer | 1 | August 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Boston Easy Biotech Inc | Belmont, MA, 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 | |
| Premier Medical Corporation Private Limited | VALSAD Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Medical Usa Corporation | Somerset, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 27, 2018. 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.