QIC
- Product code
- QIC
- Device name
- Hiv-1 Genotyping Assay Using Ngs Technology
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3955
- Medical specialty
- Medical Genetics
- Marketing pathway
- 510(K)
FDA classification 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.
Official FDA classification page: QIC
Classification and pathway per current FDA publications. Data from openFDA (CC0).