STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
Device Facts
| Record ID | K933464 |
|---|---|
| Device Name | STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY |
| Applicant | Baxter Diagnostics, Inc. |
| Product Code | CHP · Clinical Chemistry |
| Decision Date | Oct 22, 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.
