FDA product code QIC: Hiv-1 Genotyping Assay Using Ngs Technology
QIC is the FDA product code for hiv-1 genotyping assay using ngs technology. It is a Class II device, regulated under 21 CFR 866.3955 and reviewed by the Microbiology panel. Devices under QIC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology is a prescription in vitro diagnostic device intended for use in detecting HIV genomic mutations that confer resistance to specific anti-retroviral drugs. The device is intended to be used as an aid in monitoring and treating HIV infection.
Classification
| Field | Value |
|---|---|
| Device name | Hiv-1 Genotyping Assay Using Ngs Technology |
| Device class | Class II |
| Regulation | 21 CFR 866.3955 |
| Review panel | MI — Microbiology |
| Medical specialty | Medical Genetics |
| Premarket route | 510(k) |
Recalls for QIC devices
openFDA lists no recalls for product code QIC.
Frequently asked questions
What is FDA product code QIC?
QIC is the FDA product code for hiv-1 genotyping assay using ngs technology. It is a Class II device, regulated under 21 CFR 866.3955 and reviewed by the Microbiology panel.
What device class is QIC?
Class II, regulation 21 CFR 866.3955. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QIC
- Run a recall and safety report across every QIC manufacturer
- Watch product code QIC 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.