| Device |
salivary estriol test |
| Definition |
To detect and measure salivary estriol in pregnant women. |
| Physical State |
Pregnancy |
| Technical Method |
Enzyme linked immunoabsorbent assay |
| Target Area |
saliva sample |
| Review Panel |
Clinical Chemistry |
| Product Code | PEJ |
| Submission Type |
PMA
|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|