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U.S. Department of Health and Human Services

Product Classification

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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).
Physical State Dengue nucleic acid amplification and detection reagents including primers and probes, positive controls, and human specimen extraction control
Technical Method Uses nucleic acid amplification technology for detection of dengue virus target sequences
Target Area Human clinical samples e.g., blood serum, plasma
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOZB
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3946
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible