Product code
QSU: Point of care hiv serology diagnostic and/or supplemental test
FDA product code · Class II · Microbiology
Key facts
| Product code | QSU |
|---|---|
| Device | Point of care hiv serology diagnostic and/or supplemental test |
| Device class | Class II |
| Regulation number | 866.3956 |
| 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) Point of Care serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV in human body fluids or tissues. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- 10–99 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