RIA-120 AND ESTRIOL REAGENT SYSTEM
Device Facts
| Record ID | K770465 |
|---|---|
| Device Name | RIA-120 AND ESTRIOL REAGENT SYSTEM |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | CGI · Clinical Chemistry |
| Decision Date | Jun 2, 1977 |
| 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.
