# Hiv-1 Genotyping Assay Using Ngs Technology
> **Product code: QIC** · Class II — Moderate Risk (510(k) clearance required) · Medical Genetics · 21 CFR 866.3955
## Classification
- **FDA Product Code:** QIC
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3955
- **Review panel:** MI
- **Medical specialty:** Medical Genetics
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QIC)
---
*AI Analytics · CC0 1.0*