REAGENT SYSTEM, SIGMA PROCEDURE NO. 270
Device Facts
| Record ID | K760348 |
|---|---|
| Device Name | REAGENT SYSTEM, SIGMA PROCEDURE NO. 270 |
| Applicant | Sigma Chemical Co. |
| Product Code | CCZ · Clinical Chemistry |
| Decision Date | Oct 27, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1385 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone moiety on the steroid nucleus in urine. Corticosteroids with this chemical configuration include cortisol, cortisone 11-desoxycortisol, desoxycorticosterone, and their tetrahydroderivatives. This group of hormones is synthesized by the adrenal gland. Measurements of 17-hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis and treatment of various diseases of the adrenal or pituitary glands and gonadal disorders.
