FDA product code QSS: Hiv Self-Tests
QSS is the FDA product code for hiv self-tests. It is a Class III device, reviewed by the Microbiology panel. Devices under QSS reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Human immunodeficiency virus (HIV) self-tests are intended for use by an individual to test themselves for the presence of HIV in body fluids.
Classification
| Field | Value |
|---|---|
| Device name | Hiv Self-Tests |
| Device class | Class III |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QSS devices
openFDA lists no recalls for product code QSS.
Frequently asked questions
What is FDA product code QSS?
QSS is the FDA product code for hiv self-tests. It is a Class III device, reviewed by the Microbiology panel.
What device class is QSS?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QSS
- Run a recall and safety report across every QSS manufacturer
- Watch product code QSS 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.
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