Salivary Estriol Test
FDA product code PEJ · Class III (high risk) · Clinical Chemistry
To detect and measure salivary estriol in pregnant women.
0510(k) clearances
1PMA approvals
1recalls
PMA approvals
- P970032 Salest TM System · Hologic, Inc. · 04/29/1998
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2836-2018 Class II | Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of…Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1. | DRG Instruments GmbH | 07/14/2016Terminated |