Product code
MZO: Assay, enzyme linked immunosorbent, hepatitis c virus
FDA product code · Class II · Microbiology
Key facts
| Product code | MZO |
|---|---|
| Device | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Device class | Class II |
| Review panel | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- 10–99 PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1,000+ 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