Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart D — Serological Reagents](/submissions/IM/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3950](/submissions/IM/subpart-d%E2%80%94serological-reagents/866.3950) → NHS — Assay, Genotype, Hiv Drug Resistance, In Vitro

# NHS · Assay, Genotype, Hiv Drug Resistance, In Vitro

_Immunology · 21 CFR 866.3950 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/NHS

## Overview

- **Product Code:** NHS
- **Device Name:** Assay, Genotype, Hiv Drug Resistance, In Vitro
- **Regulation:** [21 CFR 866.3950](/submissions/IM/subpart-d%E2%80%94serological-reagents/866.3950)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

The in vitro HIV drug resistance genotype assay is a device that consists of nucleic acid reagent primers and probes together with software for predicting drug resistance/susceptibility based on results obtained with these primers and probes. It is intended for use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs, as an aid in monitoring and treating HIV infection.

## Classification Rationale

Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.” See § 866.1(e) for the availability of this guidance document.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.” See § 866.1(e) for the availability of this guidance document.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/NHS](https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/NHS)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com