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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dengue nucleic acid amplification assay (naat)
Regulation Description Dengue virus nucleic acid amplification test reagents.
Definition A qualitative in vitro diagnostic assay for the detection of dengue virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe).
Product CodeOZB
Regulation Number 866.3946
Device Class 2

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