# Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test
> **Product code: QSV** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3957
## Classification
- **FDA Product Code:** QSV
- **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) Point of Care 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:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QSV)
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