| 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). |
| 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 Code | OZB |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3946
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
