VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
Device Facts
| Record ID | K970643 |
|---|---|
| Device Name | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) |
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc. |
| Product Code | CHP · Clinical Chemistry |
| Decision Date | Mar 18, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1260 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
