Product code
NWY: Test, qualitative, detection of dengue igm and igg antibodies
FDA product code · Not Classified · Microbiology
Key facts
| Product code | NWY |
|---|---|
| Device | Test, qualitative, detection of dengue igm and igg antibodies |
| Device class | Not Classified |
| Review panel | Microbiology |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database