Product code
QST: Lab-based hiv nat diagnostic and/or supplemental test
FDA product code · Class II · Microbiology
Key facts
| Product code | QST |
|---|---|
| Device | Lab-based hiv nat diagnostic and/or supplemental test |
| Device class | Class II |
| Regulation number | 866.3957 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Human immunodeficiency virus (HIV) lab-based nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 1–9 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