Product code
PTC: Uric acid test system for at home prescription use
FDA product code · Class I · Clinical Chemistry
Key facts
| Product code | PTC |
|---|---|
| Device | Uric acid test system for at home prescription use |
| Device class | Class I |
| Regulation number | 862.1775 |
| Review panel | Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only. |
At a glance
- 1–9 510(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