FDA product code QSV: Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test
QSV is the FDA product code for point of care hiv nat diagnostic and/or supplemental test. It is a Class II device, regulated under 21 CFR 866.3957 and reviewed by the Microbiology panel. Devices under QSV reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Human immunodeficiency virus (HIV) Point of Care nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues.
Classification
| Field | Value |
|---|---|
| Device name | Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test |
| Device class | Class II |
| Regulation | 21 CFR 866.3957 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for QSV devices
openFDA lists no recalls for product code QSV.
Frequently asked questions
What is FDA product code QSV?
QSV is the FDA product code for point of care hiv nat diagnostic and/or supplemental test. It is a Class II device, regulated under 21 CFR 866.3957 and reviewed by the Microbiology panel.
What device class is QSV?
Class II, regulation 21 CFR 866.3957. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QSV
- Run a recall and safety report across every QSV manufacturer
- Watch product code QSV 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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