Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test

QUM · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3958

Classification

FDA Product Code: QUM
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3958
Review panel: CH
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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

Market data

Cleared 510(k) submissions: 0
Registered establishments: 6

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown