ULTRA-SENSITIVE ESTRADIOL
Device Facts
| Record ID | K953605 |
|---|---|
| Device Name | ULTRA-SENSITIVE ESTRADIOL |
| Applicant | Diagnostic Systems Laboratories, Inc. |
| Product Code | CHP · Clinical Chemistry |
| Decision Date | Oct 2, 1995 |
| 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.
