510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QUMClass II

Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test

21 CFR 866.3958 / Microbiology
FDA source (opens on fda.gov)

QUM is the FDA product code for Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test, a class II device type, regulated under 21 CFR 866.3958. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QUM
Device name
Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test
FDA 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
Regulation
21 CFR 866.3958
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

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