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 Code | OZB |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
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 Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |