Product code
PRE: Rt-qpcr assay for mrna transcript immune biomarkers
FDA product code · Class II · Microbiology
Key facts
| Product code | PRE |
|---|---|
| Device | Rt-qpcr assay for mrna transcript immune biomarkers |
| Device class | Class II |
| Regulation number | 866.3215 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood. |
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