SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY
Device Facts
| Record ID | K850787 |
|---|---|
| Device Name | SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY |
| Applicant | Nms Pharmaceuticals, Inc. |
| Product Code | CGI · Clinical Chemistry |
| Decision Date | Mar 26, 1985 |
| 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.
