Product code QIC

Device name

Hiv-1 Genotyping Assay Using Ngs Technology

Medical specialty

Medical Genetics

Device class

2

Regulation number

866.3955

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset