FDA product code QST: Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test
QST is the FDA product code for lab-based 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 QST reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Human immunodeficiency virus (HIV) lab-based 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 | Lab-Based 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 QST devices
openFDA lists no recalls for product code QST.
Frequently asked questions
What is FDA product code QST?
QST is the FDA product code for lab-based 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 QST?
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 QST
- Run a recall and safety report across every QST manufacturer
- Watch product code QST 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.