FDA product code QUM: Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test
QUM is the FDA product code for human immunodeficiency virus (hiv) viral load monitoring test. It is a Class II device, regulated under 21 CFR 866.3958 and reviewed by the Clinical Chemistry panel. Devices under QUM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
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
Classification
| Field | Value |
|---|---|
| Device name | Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test |
| Device class | Class II |
| Regulation | 21 CFR 866.3958 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for QUM devices
openFDA lists no recalls for product code QUM.
Frequently asked questions
What is FDA product code QUM?
QUM is the FDA product code for human immunodeficiency virus (hiv) viral load monitoring test. It is a Class II device, regulated under 21 CFR 866.3958 and reviewed by the Clinical Chemistry panel.
What device class is QUM?
Class II, regulation 21 CFR 866.3958. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QUM
- Run a recall and safety report across every QUM manufacturer
- Watch product code QUM 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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