COAT-A-COUNT FREE ESTRIOL
Device Facts
| Record ID | K932989 |
|---|---|
| Device Name | COAT-A-COUNT FREE ESTRIOL |
| Applicant | Diagnostic Products Corp. |
| Product Code | CGI · Clinical Chemistry |
| Decision Date | Dec 19, 1994 |
| 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.
