QUM — Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test Class II
FDA product code QUM covers "Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test", a Class II medical device regulated under 21 CFR 866.3958. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- QUM
- Device Class
- Class II
- Regulation Number
- 866.3958
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Microbiology
- Implant
- No
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