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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 nat diagnostic and/or supplemental test
Regulation Description Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or supplemental test.
Definition Human immunodeficiency virus (HIV) Point of Care nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues.
Product CodeQSV
Regulation Number 866.3957
Device Class 2

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