Device |
dengue nucleic acid amplification assay (naat) |
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 Code | OZB |
Regulation Number |
866.3946
|
Device Class |
2
|
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