Product code
QUM: Human immunodeficiency virus (hiv) viral load monitoring test
FDA product code · Class II · Clinical Chemistry
Key facts
| Product code | QUM |
|---|---|
| Device | Human immunodeficiency virus (hiv) viral load monitoring test |
| Device class | Class II |
| Regulation number | 866.3958 |
| Review panel | Clinical Chemistry |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A human immunodeficiency virus (HIV) viral load monitoring test is an in vitro diagnostic prescription device for the quantitation of the amount of HIV ribonucleic acid (RNA) in human body fluids |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 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