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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device human immunodeficiency virus (hiv) viral load monitoring test
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
Product CodeQUM
Regulation Number 866.3958
Device Class 2

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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