Device |
hiv-1 genotyping assay using ngs technology |
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. |
Product Code | QIC |
Regulation Number |
866.3955
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Device Class |
2
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