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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lab-based hiv nat diagnostic and/or supplemental test
Definition Human immunodeficiency virus (HIV) lab-based nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues.
Product CodeQST
Regulation Number 866.3957
Device Class 2

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

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