Hiv-1 Genotyping Assay Using Ngs Technology

QIC · Class II — Moderate Risk (510(k) clearance required) · Medical Genetics · 21 CFR 866.3955

Classification

FDA Product Code: QIC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3955
Review panel: MI
Medical specialty: Medical Genetics
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown