Device |
dengue virus antigen assay |
Regulation Description |
Dengue virus serological reagents. |
Definition |
Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection |
Physical State |
ELISA Kit including different components, i.e., ELISA plates coated with antibodies, other capture antibodies, positive and negative controls etc. |
Technical Method |
Immunoassay e.g., ELISA |
Target Area |
Human serum or plasma or whole blood or body fluid collected from patient |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | QCU |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3945
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |