Product code QSU
- Device name
- Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3956
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Human immunodeficiency virus (HIV) Point of Care serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV in human body fluids or tissues.
- Source
- FDA openFDA device classification dataset