QIC — Hiv-1 Genotyping Assay Using Ngs Technology Class II
FDA product code QIC covers "Hiv-1 Genotyping Assay Using Ngs Technology", a Class II medical device regulated under 21 CFR 866.3955. Submissions are reviewed by the Medical Genetics panel.
Classification Details
- Product Code
- QIC
- Device Class
- Class II
- Regulation Number
- 866.3955
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Medical Genetics
- Implant
- No
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.