FDA product code QSU: Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test
QSU is the FDA product code for point of care hiv serology diagnostic and/or supplemental test. It is a Class II device, regulated under 21 CFR 866.3956 and reviewed by the Microbiology panel. Devices under QSU reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test |
| Device class | Class II |
| Regulation | 21 CFR 866.3956 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for QSU devices
openFDA lists no recalls for product code QSU.
Frequently asked questions
What is FDA product code QSU?
QSU is the FDA product code for point of care hiv serology diagnostic and/or supplemental test. It is a Class II device, regulated under 21 CFR 866.3956 and reviewed by the Microbiology panel.
What device class is QSU?
Class II, regulation 21 CFR 866.3956. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QSU
- Run a recall and safety report across every QSU manufacturer
- Watch product code QSU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times