Product code
OQS: Laboratory developed test
FDA product code · Not Classified · Pathology
Key facts
| Product code | OQS |
|---|---|
| Device | Laboratory developed test |
| Device class | Not Classified |
| Review panel | Pathology |
| Submission type | Enforcement Discretion |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A clinical diagnostic test for use in the diagnosis of disease or other conditions that was developed by CLIA certified clinical laboratory for use in that laboratory. This product is neither an Analyte Specific Reagent nor are the components for Research Use Only. The reporting of adverse events is voluntary and registering and listing is not required. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None 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