FDA product code QSS
Hiv Self-Tests
Unknown·Class 3·21 CFR
US regulatory classifications
- US Product Code (FDA)
- QSSView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFRView CFR Regulation →
- Medical specialty
- Unknown
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Human immunodeficiency virus (HIV) self-tests are intended for use by an individual to test themselves for the presence of HIV in body fluids.
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About this record
Hiv Self-Tests is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.