Product code QUM
- Device name
- Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3958
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A human immunodeficiency virus (HIV) viral load monitoring test is an in vitro diagnostic prescription device for the quantitation of the amount of HIV ribonucleic acid (RNA) in human body fluids
- Source
- FDA openFDA device classification dataset