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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device point of care hiv serology diagnostic and/or supplemental test
Definition Human immunodeficiency virus (HIV) Point of Care serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV in human body fluids or tissues.
Product CodeQSU
Regulation Number 866.3956
Device Class 2

MDR Year MDR Reports MDR Events
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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