QUM

Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test

Product code: QUM
Device name: Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test
Device class: Class 2
21 CFR: 21 CFR 866.3958
Medical specialty: Microbiology
Marketing pathway: 510(K)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QUM

Classification and pathway per current FDA publications. Data from openFDA (CC0).