| Device |
zika virus serological reagents |
| Definition |
Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings. |
| Physical State |
In Vitro Diagnostic antigens and antisera; ELISA Kit including different components, i.e., ELISA plates coated with antibodies, other capture antibodies, positive and negative controls etc. |
| Technical Method |
Immunological methods e.g., ELISA |
| Target Area |
Human serum or plasma or whole blood or body fluid collected from patient; none of the body parts will utilize the device or are intended to be affected by the device. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | QFO |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3935
|
|---|
| 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
|
|---|
| Third Party Review |
Not Third Party Eligible |
