NATAL-TEC ESTRIOL
Device Facts
| Record ID | K811371 |
|---|---|
| Device Name | NATAL-TEC ESTRIOL |
| Applicant | Armkel, LLC |
| Product Code | CGI · Clinical Chemistry |
| Decision Date | May 29, 1981 |
| 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.
