Salivary Estriol Test
Device Code: 719
Product Code(s):
PEJ Definition: To Detect And Measure Salivary Estriol In Pregnant Women.
Device Classification Information
| Device Type ID | 719 |
| Device Name | Salivary Estriol Test |
| Physical State | Pregnancy |
| Technical Method | Enzyme Linked Immunoabsorbent Assay |
| Target Area | Saliva Sample |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PEJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 719 |
| Device | Salivary Estriol Test |
| Product Code | PEJ |
| FDA Device Classification | Class 3 Medical Device |
| Recalls |
|---|
| Manufacturer | Recall Class | Date Posted |
| 1 | DRG Instruments GmbH | II | Aug-16-2018 |
TPLC Last Update: 2019-04-02 19:39:42