IMMOPHASE D-TE 3 RADIOIMMUNOASSAY
Device Facts
| Record ID | K833406 |
|---|---|
| Device Name | IMMOPHASE D-TE 3 RADIOIMMUNOASSAY |
| Applicant | Corning Medical & Scientific |
| Product Code | CGF · Clinical Chemistry |
| Decision Date | Jan 24, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1280 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.
