VIDAS ESTRADIOL (E2) ASSAY
Device Facts
| Record ID | K925498 |
|---|---|
| Device Name | VIDAS ESTRADIOL (E2) ASSAY |
| Applicant | Biomerieux Vitek, Inc. |
| Product Code | CHP · Clinical Chemistry |
| Decision Date | Feb 12, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1260 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
