Product code
PYP: Low-density lipoprotein (ldl) cholesterol sub-fraction test
FDA product code · Class I · Clinical Chemistry
Key facts
| Product code | PYP |
|---|---|
| Device | Low-density lipoprotein (ldl) cholesterol sub-fraction test |
| Device class | Class I |
| Regulation number | 862.1475 |
| 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 determination of low-density lipoprotein (LDL) cholesterol sub-fractions. |
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
- 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