ARIA II 125- I-ESTRIOL SYSTEM
Device Facts
| Record ID | K801735 |
|---|---|
| Device Name | ARIA II 125- I-ESTRIOL SYSTEM |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | CGI · Clinical Chemistry |
| Decision Date | Sep 16, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1265 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.
