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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeQIC
Regulation Number 866.3955
Device Class 2

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