# Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test
> **Product code: QST** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3957
## Classification
- **FDA Product Code:** QST
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3957
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Human immunodeficiency virus (HIV) lab-based nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QST)
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