| Device |
vaginitis and bacterial vaginosis nucleic acid detection system |
| Definition |
A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections. |
| Physical State |
In vitro device consisting of reagents and associated instrumentation for detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. |
| Technical Method |
Qualitative in vitro diagnostic device that detects nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. |
| Target Area |
In vitro diagnostic device |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | PQA |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3975
|
|---|
| 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
|
|---|
| Third Party Review |
Not Third Party Eligible |
